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Item 1A. Risk Factors

2021-03-16 compared with 2020-03-02 · 1534 added, 1522 removed, 59 unchanged (98% of the section changed)

investment in our common stock involves a high degree of risk.

You should carefully consider the following risk factors and the

other information in this Annual Report on Form 10-K before investing in our common stock.

Our business and results of operations

could be seriously harmed by any of the following risks.

An investment in our common stock involves

a high degree of risk.

You should carefully consider the following risk factors and the other information in this Annual Report

on Form 10-K before investing in our common stock.

Our business and results of operations could be seriously harmed by any of the

following risks.

The risks set out below are not the only risks we face.

Additional risks

and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our

business, financial condition and/or operating results.

If any of the following events occur, our business, financial condition

and results of operations could be materially adversely affected.

In such case, the value and trading price of our common stock

could decline, and you may lose all or part of your investment.

Related to Our Financial Position and Need for Capital

have generated no revenue from commercial sales to date and our future profitability is uncertain.

were incorporated in May 2017 and have a limited operating history and our business is subject to all of the risks inherent in

the establishment of a new business enterprise.

Our likelihood of success must be considered in light of the problems, expenses,

difficulties, complications and delays frequently encountered in connection with development and expansion of a new business enterprise.

Since inception, we have incurred losses and expect to continue to operate at a net loss for at least the next several years as

we commence our research and development efforts, conduct clinical trials and develop manufacturing, sales, marketing and distribution

capabilities.

Our net losses for the year ended December 31, 2019 and 2018 were $7,704,636 and $2,495,525, respectively, and our

accumulated deficit as of December 31, 2019 and 2018 was $12,215,642 and $4,511,006, respectively.

There can be no assurance that

the products under development by us will be approved for sale in the U.S.

Additional risks and uncertainties not currently known

to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition and/or

operating results.

If any of the following events occur, our business, financial condition and results of operations could be materially

adversely affected.

In such case, the value and trading price of our common stock could decline, and you may lose all or part of

your investment.

Risks Related to Our Financial Position

and Need for Capital

We have generated no revenue from commercial

sales to date and our future profitability is uncertain.

We were incorporated in May 2017 and have a

limited operating history and our business is subject to all of the risks inherent in the establishment of a new business enterprise.

Our likelihood of success must be considered in light of the problems, expenses, difficulties, complications and delays frequently

encountered in connection with development and expansion of a new business enterprise.

Since inception, we have incurred losses

and expect to continue to operate at a net loss for at least the next several years as we commence our research and development

efforts, conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

Our net losses for

the years ended December 31, 2020 and 2019 were $7,197,816 and $7,704,636, respectively, and our accumulated deficit as of December

31, 2020 and 2019 was $19,413,458 and $12,215,642, respectively.

There can be no assurance that the products under development

by us will be approved for sale in the U.S.

or elsewhere.

Furthermore, there can be no assurance

that if such products are approved they will be successfully commercialized, and the extent of our future losses and the timing

of our profitability are highly uncertain.

Furthermore, there can be no assurance that if such products are approved

they will be successfully commercialized, and the extent of our future losses and the timing of our profitability are highly uncertain.

If we are unable to achieve profitability, we may be unable to continue our operations.

independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern,

which may hinder our ability to obtain future financing.

financial statements as of December 31, 2019 have been prepared under the assumption that we will continue as a

going concern for the next twelve months.

Our independent registered public accounting firm included in its opinion for the

year ended December 31, 2019 an explanatory paragraph referring to our recurring losses from operations and expressing substantial

doubt in our ability to continue as a going concern without additional capital becoming available.

Our ability to continue as

a going concern is dependent upon our ability to obtain additional equity or debt financing, reduce expenditures and to generate

significant revenue.

Our financial statements as of December 31, 2019 did not include any adjustments that might result

from the outcome of this uncertainty.

The reaction of investors to the inclusion of a going concern statement by our auditors,

and our potential inability to continue as a going concern, in future years could materially adversely affect our share price

and our ability to raise new capital or enter into strategic alliances.

Furthermore, we also could be required to seek funds through

arrangements with collaborative partners or otherwise that may require us to relinquish rights to some of our technologies or

product candidates or otherwise agree to terms unfavorable to us.

we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development

and you will likely lose your entire investment.

will need to continue to seek capital from time to time to continue development of our lead drug candidate beyond the initial

Phase 2 clinical trial and to acquire and develop other product candidates.

Our first product is not expected to be commercialized

until at least 2022 and we cannot provide any assurances that any revenues it may generate in the future will be sufficient to

fund our ongoing operations.

We believe that we will need to raise substantial additional capital to fund our continuing operations

and the development and commercialization of our product candidate.

business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial

additional funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary

products, business or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory

environment or a change in preferred eczema treatment modalities.

In addition, we may need to accelerate the growth of our sales

capabilities and distribution beyond what is currently envisioned, and this would require additional capital.

However, we may

not be able to secure funding when we need it or on favorable terms.

We may not be able to raise sufficient funds to commercialize

the product candidates we intend to develop.

we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research

and development activities, clinical studies or future operations.

We may also be required to obtain funds through arrangements

with collaborators, which arrangements may require us to relinquish rights to certain technologies or products that we otherwise

would not consider relinquishing, including rights to future product candidates or certain major geographic markets.

result in sharing revenues which we might otherwise retain for ourselves.

Any of these actions may harm our business, financial

condition and results of operations.

amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our pre-clinical studies and clinical trials;

the time and cost necessary to obtain regulatory

the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing;

ability to enter into and maintain collaborative, licensing and other commercial relationships;

If we fail to obtain the capital necessary

to fund our operations, we will be unable to continue or complete our product development and you will likely lose your entire

We will need to continue to seek capital from

time to time to continue development of our product candidates.

We cannot provide any assurances that any revenues that we may

generate in the future will be sufficient to fund our ongoing operations.

We believe that we will need to raise substantial additional

capital to fund our operations and the development and commercialization of our product candidates.

Our business or operations may change in a

manner that may consume available funds more rapidly than anticipated and substantial additional funding may be required to maintain

operations, fund expansion, commercialize our product candidates, develop new or enhanced products, acquire complementary products,

business or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment

or a change in preferred treatment modalities.

In addition, we may need to accelerate the growth of our sales capabilities and

distribution beyond what is currently envisioned, and this would require additional capital.

However, we may not be able to secure

funding on favorable terms, if at all.

If we cannot raise adequate funds to satisfy

our capital requirements, we may have to delay, scale back or eliminate our research and development activities, clinical studies

or operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements may require

us to relinquish rights to certain intellectual property, technologies or products that we otherwise would not consider relinquishing,

including rights to future product candidates or certain major geographic markets.

This could result in sharing revenues which

we might otherwise retain for ourselves.

Any of these actions may harm our business, financial condition and results of operations.

The amount of capital we may need depends on

many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our

pre-clinical studies and clinical trials;

the time and cost necessary to obtain regulatory approvals;

the time and cost necessary

to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative,

licensing and other commercial relationships;

and our partners’

of time and resources to the development and commercialization of our products.

if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

capital markets have been unpredictable in the recent past for unprofitable companies such as ours.

In addition, it is generally

difficult for early stage companies to raise capital under current market conditions.

The amount of capital that a company such

as ours is able to raise often depends on variables that are beyond our control.

As a result, we may not be able to secure financing

on terms attractive to us, or at all.

If we are able to consummate a financing arrangement, the amount raised may not be sufficient

to meet our future needs.

If adequate funds are not available on acceptable terms, or at all, our business, including our results

of operations, financial condition and our continued viability will be materially adversely affected.

Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

depend upon the success of the BioLexa Platform, which has not yet demonstrated efficacy in Phase 2 clinical trials, as well as

our other licensed products and technologies.

If we are unable to generate revenues from the BioLexa Platform or our other licensed

products and technologies, our ability to create stockholder value will be limited.

intend to conduct our first Phase 1 study in healthy adults with an immediate transition to a randomized, vehicle controlled Phase

1b trial in adolescent eczema patients comparing BioLexa to the base vehicle.

Following our Phase 1b trial, we intend to conduct

up to two Phase 2 trials in atopic dermatitis patients comparing BioLexa to the base vehicle.

We expect the clinical program to

be completed, subject to receipt of funding by us, by the end of 2020 or early 2021 with an NDA submission targeted for mid to

In addition, we have licensed a genetic

marker for food allergies, products and technology for therapeutic uses related to lupus in human beings, patents related to an

exon skipping approach for treating allergic diseases and patents related to aprepitant which is used to treat side effects from

drugs used for the treatment of cancer.

We do not generate revenues from any drug products.

We may not be successful in obtaining

acceptance from the regulatory authorities to start our clinical trials.

If we do not obtain such acceptance, the time in which

we expect to commence clinical programs for any product candidate will be extended and such extension will increase our expenses

and increase our need for additional capital.

Moreover, there is no guarantee that our clinical trials will be successful or that

we will continue clinical development in support of an approval from the regulatory authorities for any indication.

most drug candidates never reach the clinical stage and even those that do commence clinical development have only a small chance

of successfully completing clinical development and gaining regulatory approval.

Therefore, our business currently depends entirely

on the successful development, regulatory approval and commercialization of our product candidates, which may never occur.

of our management team lack experience in the pharmaceutical field.

This lack of experience may impair our ability to commercialize

our pharmaceutical products and attain profitability.

We will need to hire or engage managerial personnel with relevant experience

in the pharmaceutical field;

however, there can be no assurance that such personnel will be available to us or, that once engaged,

will be retained by us.

Failure to establish and maintain an effective management team with experience in the pharmaceutical field

and commercialization of pharmaceuticals products would have a material adverse effect on our business and results of operations.

marketing approval process of the FDA is lengthy, time consuming and inherently unpredictable, and if we are ultimately are unable

to obtain marketing approval for the product candidates we intend to develop, our business will be substantially harmed.

of the product candidates we intend to develop have gained marketing approval in the U.S.

and we cannot guarantee that we will

commitment of time and resources to the development and commercialization

of our products.

Even if we can raise additional funding,

we may be required to do so on terms that are dilutive to you.

The capital markets have been unpredictable

in the recent past for unprofitable companies such as ours.

The amount of capital that a company such as ours is able to raise

often depends on variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive

to us, or at all.

If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future

If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial

condition and our continued viability will be materially adversely affected.

Risks Related to Product Development, Regulatory

Approval, Manufacturing and Commercialization

We are dependent upon the clinical success

of our licensed products and technologies.

If we are unable to generate revenues from our licensed products and technologies, our

ability to create shareholder value may be limited.

We do not currently generate revenues from

any of our product candidates, and we may not be successful in obtaining regulatory approvals to commence our clinical trials.

If we do not obtain such approvals, the time in which we expect to commence clinical programs for our product candidates will be

extended and such extension may increase our expenses and our need for additional capital.

Moreover, there is no guarantee that

our clinical trials will be successful or that we will continue clinical development in support of an approval from the regulatory

agencies for any indication.

We note that most drug candidates never reach the clinical stage and even those that do commence clinical

development have only a small chance of successfully completing clinical development and gaining regulatory approval.

our business currently depends entirely on the successful development, regulatory approval and commercialization of our product

candidates, which may never occur.

Although we have entered into the Voltron

Agreement pursuant to which we and HaloVax intend to jointly develop products to prevent COVID-19, no assurance can be given as

to when, if ever, we will be able to develop any products for such purpose and if developed that such products will be successfully

commercialized.

On March 23, 2020, we entered into the Voltron

Agreement pursuant to which we and HaloVax will work to jointly develop potential products candidates to prevent COVID-19;

no assurance can be given as to when, if ever, we will be able to develop any products for such purpose.

Furthermore, we are subject

to risks including, but not limited to, the following with respect to the development of a treatment for COVID-19:

the Emergency Use Authorization marketing approval processes of the FDA are lengthy, time consuming and inherently unpredictable, and we cannot guarantee that we will ever have a marketable product;

we may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities;

conducting successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit;

to be commercially successful, physicians must be persuaded that using our products are effective alternatives to other existing therapies and treatments;

we may depend on third parties for manufacturing our proposed product candidates and any conflicts with such partners could delay or prevent the development or commercialization of such product candidates;

if third-party contract manufacturers upon whom we rely to formulate and manufacture our product candidates do not perform, fail to manufacture according to our specifications or fail to comply with strict regulations, our clinical studies could be adversely affected and the development of our product candidates could be delayed or terminated or we could incur significant additional expenses;

adverse events involving our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could harm our reputation, business and financial results;

if we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected.

If our joint venture with HaloVax is

not successful or if we fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on

the full market potential of our potential products.

On March 23, 2020, we entered into the Voltron

Agreement to form a joint venture entity named HaloVax to jointly develop potential product candidates for the prevention of the

COVID-19 based upon certain technology that had been exclusively licensed by Voltron from Mass Gen.

Pursuant to the terms of the

Voltron Agreement we are entitled to receive sales-based royalties at low single digit percentages.

In addition, on March 23, 2020

and May 28, 2020, we entered into membership purchase agreements with HaloVax pursuant to which we purchased 5% and 1% of HaloVax’s

outstanding membership interests, respectively.

Furthermore, we shall contribute proceeds of the development of products to prevent

If and to the extent we and HaloVax are unable to develop potential product candidates for the prevention of COVID-19,

we will not be entitled to any sale-based royalties the value of our ownership interest in HaloVax could decline in which case

we may lose all or part of our investment in HaloVax.

While Voltron has

agreed to cooperate and use commercially reasonable efforts to exchange information and resources that will lead to the development

activities, and established a Joint Development Committee consisting of seven members, two of which were selected by us, to plan,

review, coordinate and oversee the performance of the development activities and timelines with respect to development activities,

we have limited contractual rights to direct its activities.

Moreover, we will not have any other control with respect to the operations

Therefore, HaloVax will have a greater influence with respect to its commercialization efforts and other operations.

In general, our joint venture with HaloVax subjects us to a number of related risks including that:

we may not receive sales-based royalties pursuant to the terms of the Voltron Agreement;

we may not be successful in the development of any product candidates;

HaloVax may not commit sufficient resources to the marketing and distribution of our products;

HaloVax may infringe the intellectual property rights of third parties, which may expose us to litigation and other potential liability;

disputes may arise between us and HaloVax that result in the delay or termination of the commercialization of our products or product candidates or that result in costly litigation or arbitration that diverts management attention and resources including, but not limited to, disputes with respect to commercializing products upon terms mutually agreeable or beneficial to us and HaloVax;

any products, if developed, will be sold or licensed on terms that are beneficial to us;

HaloVax may not provide us with timely and accurate information regarding commercialization status or results, which could adversely impact our ability to manage our own commercialization efforts, accurately forecast financial results or provide timely information to our shareholders regarding our commercialization efforts;

if any product candidates are successfully developed that we will be able to commercialize such products upon terms mutually agreeable or beneficial to us and HaloVax.

The marketing approval process of the

FDA is lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for the

product candidates we intend to develop, our business may be substantially harmed.

None of the product candidates we intend to

develop have gained marketing authorization, approval or clearance in the U.S.

or elsewhere, and we cannot guarantee that we will

ever have marketable products.

2 unchanged sentences

We cannot commercialize our product candidates

in the United States without first obtaining approval from the FDA to market each product candidate.

Our product candidates could

fail to receive marketing approval for many reasons, including among others:

FDA may disagree with the design or implementation of our clinical trials;

FDA could determine that we cannot rely on Section 505(b)(2) for any or all of our product candidates;

FDA may determine that we have identified the wrong reference listed drug or drugs or that approval of our Section 505(b)(2)

application for any of our product candidates is blocked by patent or non-patent exclusivity of the reference listed drug

addition, the process of seeking regulatory clearance or approval to market the product candidates we intend to develop is expensive

and time consuming and, notwithstanding the effort and expense incurred, clearance or approval is never guaranteed.

not successful in obtaining timely clearance or approval of our product candidates from the FDA, we may never be able to generate

significant revenue and may be forced to cease operations.

in the United States or elsewhere without first obtaining approval from regulatory agencies such as the FDA to market each product

Our product candidates could fail to receive marketing approval for many reasons, including among others:

the FDA or other regulatory agencies may disagree with the design or implementation of our clinical trials;

the FDA could determine that we cannot rely on Section 505(b)(2) for any of our product candidates;

the FDA may determine that we have identified the wrong reference listed drug or drugs or that approval of our Section 505(b)(2) application for any of our product candidates is blocked by patent or non-patent exclusivity of the reference listed drug or drugs.

In addition, the process of seeking regulatory

clearance or approval to market the product candidates we intend to develop is expensive and time consuming and, notwithstanding

the effort and expense incurred, clearance or approval is never guaranteed.

If we are not successful in obtaining timely clearance

or approval of our product candidates from the FDA or other foreign regulatory agencies, we may never be able to generate significant

revenue and may be forced to cease operations.

The NDA process is costly, lengthy and uncertain.

Any NDA application

filed by the Company will have to be supported by extensive data, including, but not limited to, technical, pre-clinical, clinical,

manufacturing and labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its

intended use.

clearances or approvals from the FDA and from the regulatory agencies in other countries is an expensive and time consuming process

and is uncertain as to outcome.

The FDA and other agencies could ask us to supplement our submissions, collect non-clinical data,

conduct additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

even if we obtain an NDA approval or pre-market approvals in other countries, the approval could be revoked or other restrictions

imposed if post-market data demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or when,

the FDA will act.

If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be

adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally, even if cleared or

approved, the Company’s products may not be approved for the specific indications that are most necessary or desirable for

successful commercialization or profitability.

may encounter substantial delays in completing our clinical studies which in turn will require additional costs, or we may fail

to demonstrate adequate safety and efficacy to the satisfaction of applicable regulatory authorities.

is impossible to predict if or when any of our product candidates, will prove safe or effective in humans or will receive

regulatory approval.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we

must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans.

Clinical testing

is expensive, time-consuming and uncertain as to outcome.

We cannot guarantee that any clinical studies will be conducted as planned

or completed on schedule, if at all.

A failure of one or more clinical studies can occur at any stage of testing.

may prevent successful or timely completion of clinical development include:

in reaching, or failing to reach, a consensus with regulatory agencies on study design;

in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research

organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and

may vary significantly among different CROs and trial sites;

in obtaining required IRB or Ethics Committee (“EC”) approval at each clinical study site;

in recruiting a sufficient number of suitable patients to participate in our clinical studies;

of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

to perform in accordance with the FDA’s GCPs or applicable regulatory guidelines in other countries;

in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical

in having patients complete participation in a study or return for post-treatment follow-up;

study sites or patients dropping out of a study;

or failure to address any patient safety concerns that arise during the course of a trial;

unanticipated

costs or increases in costs of clinical trials of our product candidates;

of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

in regulatory requirements and guidance that require amending or submitting new clinical protocols.

could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which

such trials are being conducted, by an independent Safety Review Board (“SRB”) for such trial or by the FDA, EMA,

or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors,

including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection

of the clinical trial operations or trial site by the FDA, EMA, or other regulatory authorities resulting in the imposition of

a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes

in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

inability to successfully complete pre-clinical and clinical development could result in additional costs to us or impair our

ability to generate revenues from product sales, regulatory and commercialization milestones and royalties.

In addition, if we

make manufacturing or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified

product candidates to earlier versions.

study delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates

or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize

our product candidates.

In addition, any delays in completing our clinical trials will increase our costs, slow down our product

candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.

these occurrences may significantly harm our business, financial condition and prospects.

In addition, many of the factors that

cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory

approval of our product candidates.

outcome of pre-clinical studies and early clinical trials may not be predictive of the success of later clinical trials, and interim

results of a clinical trial do not necessarily predict final results.

Further, pre-clinical and clinical data are often susceptible

to various interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily

in pre-clinical studies and clinical trials have nonetheless failed to obtain marketing approval.

If the results of our clinical

studies are inconclusive or if there are safety concerns or adverse events associated with our other product candidates, we may:

delayed in obtaining marketing approval for our product candidates, if approved at all;

approval for indications or patient populations that are not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings;

required to change the way the product is administered;

required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified

risk evaluation and mitigation strategy;

damage to our reputation.

Additionally,

our product candidates could potentially cause other adverse events that have not yet been predicted.

The inclusion of ill patients

in our clinical studies may result in deaths or other adverse medical events due to other therapies or medications that such patients

may be using.

As described above, any of these events could prevent us from achieving or maintaining market acceptance of our

product candidates and impair our ability to commercialize our products.

we are not able to obtain any required regulatory approvals for our product candidates, we will not be able to commercialize our

product candidates and our ability to generate revenue will be limited.

must successfully complete clinical trials for our product candidates before we can apply for marketing approval.

Even if we complete

our clinical trials, it does not assure marketing approval.

Our pre-clinical trials may be unsuccessful, which would materially

harm our business.

Even if our initial pre-clinical trials are successful, we are required to conduct clinical trials to establish

our product candidates’

safety and efficacy, before a marketing application (NDA or Biologics License Application, or BLA,

or their foreign equivalents) can be filed with the FDA, the European Medicines Agency (“EMA”), or comparable foreign

regulatory authorities for marketing approval of our product candidates.

testing is expensive, is difficult to design and implement, can take many years to complete and is uncertain as to outcome.

in early phases of pre-clinical and clinical trials does not ensure that later clinical trials will be successful, and interim

results of a clinical trial do not necessarily predict final results.

A failure of one or more of our clinical trials can occur

at any stage of testing.

We may experience numerous unforeseen events during, or as a result of, the clinical trial process that

could delay or prevent our ability to receive regulatory approval or commercialize our product candidates.

The research, testing,

manufacturing, labeling, packaging, storage, approval, sale, marketing, advertising and promotion, pricing, export, import and

distribution of drug products are subject to extensive regulation by the FDA, EMA, and other regulatory authorities in the United

States, European Union, and other countries, where regulations differ from country to country.

We are not permitted to market

our product candidates as prescription pharmaceutical products in the United States until we receive approval of an NDA from the

FDA, or in any foreign countries until we receive the requisite approval from such countries.

In the United States, the FDA generally

requires the completion of clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical development

to ensure its quality before an NDA is approved.

Any NDA application filed by us

will have to be supported by extensive data, including, but not limited to, technical, pre-clinical, clinical, manufacturing and

labeling data, to demonstrate to the FDA’s satisfaction the safety and efficacy of the product for its intended use.

Obtaining clearances or approvals from the

FDA and from regulatory agencies in other countries is an expensive and time consuming process and is uncertain as to outcome.

The FDA and other agencies could ask us to supplement our submissions, collect non-clinical data, conduct additional clinical trials

or engage in other time-consuming actions, or it could simply deny our applications.

In addition, even if we obtain an NDA approval

or pre-market approvals in other countries, the approval could be revoked or other restrictions imposed if post-market data demonstrates

safety issues or lack of effectiveness.

We cannot predict with certainty how, or when, the FDA or other regulatory agencies will

If we are unable to obtain the necessary regulatory approvals, our financial condition and cash flow may be adversely affected,

and our ability to grow domestically and internationally may be limited.

Additionally, even if cleared or approved, our products

may not be approved for the specific indications that are most necessary or desirable for successful commercialization or profitability.

We may encounter substantial delays in

completing our clinical studies which in turn will require additional costs, or we may fail to demonstrate adequate safety and

efficacy to the satisfaction of applicable regulatory authorities.

It is impossible to predict if or when any

of our product candidates will prove safe or effective in humans or will receive regulatory approval.

Before obtaining marketing

approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical studies to demonstrate

the safety and efficacy of the product candidates in humans.

Clinical testing is expensive, time-consuming and uncertain as to

We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all.

of one or more clinical studies can occur at any stage of testing.

Events that may prevent successful or timely completion of clinical

development include:

delays in reaching, or failing to reach, a consensus with regulatory agencies on study design;

delays in reaching, or failing to reach, agreement on acceptable terms with a sufficient number of prospective contract research organizations (“CROs”) and clinical study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

delays in obtaining required IRB or Ethics Committee (“EC”) approval at each clinical study site;

delays in recruiting a sufficient number of suitable patients to participate in our clinical studies;

imposition of a clinical hold by regulatory agencies, after an inspection of our clinical study operations or study sites;

failure by our CROs, other third parties or us to adhere to clinical study, regulatory or legal requirements;

failure to perform in accordance with the FDA’s GCPs or applicable regulatory guidelines in other countries;

delays in the testing, validation, manufacturing and delivery of sufficient quantities of our product candidates to the clinical sites;

delays in having patients complete participation in a study or return for post-treatment follow-up;

clinical study sites or patients dropping out of a study;

delay or failure to address any patient safety concerns that arise during the course of a trial;

unanticipated costs or increases in costs of clinical trials of our product candidates;

occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could also encounter delays if a clinical

trial is suspended or terminated by us, by the IRBs or ECs of the institutions in which such trials are being conducted, by an

independent Safety Review Board for such trial or by the FDA, Therapeutics Goods Administration (“TGA”), European

Medicines Agency (“EMA”), or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial

due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical

protocols, inspection of the clinical trial operations or trial site by the FDA, TGA, or other regulatory authorities resulting

in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using

a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Any inability to successfully complete pre-clinical

and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales,

regulatory and commercialization milestones and royalties.

In addition, if we make manufacturing or formulation changes to our

product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions.

Clinical study delays could also shorten any

periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring

products to market before we do, which could impair our ability to successfully commercialize our product candidates.

any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval

process and jeopardize our ability to commence product sales and generate revenues.

Any of these occurrences may significantly

harm our business, financial condition and prospects.

In addition, many of the factors that cause, or lead to, a delay in the commencement

or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

The outcome of pre-clinical studies and early

clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily

predict final results.

Further, pre-clinical and clinical data are often susceptible to various interpretations and analyses, and

many companies that have believed their product candidates performed satisfactorily in pre-clinical studies and clinical trials

have nonetheless failed to obtain marketing approval.

If the results of our clinical studies are inconclusive or if there are safety

concerns or adverse events associated with our other product candidates, we may:

be delayed in obtaining marketing approval for our product candidates, if approved at all;

obtain approval for indications or patient populations that are not as broad as intended or desired;

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings;

be required to change the way the product is administered;

be required to perform additional clinical studies to support approval or be subject to additional post-marketing testing requirements;

have regulatory authorities withdraw their approval of a product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy;

experience damage to our reputation.

Additionally, our product candidates could

potentially cause other adverse events that have not yet been predicted.

The inclusion of ill patients in our clinical studies

may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using.

described above, any of these events could prevent us from achieving or maintaining market acceptance of our product candidates

and impair our ability to commercialize our products.

If we are not able to obtain any required

regulatory approvals for our product candidates, we will not be able to commercialize our product candidates and our ability to

generate revenue will be limited.

We must successfully complete clinical trials

for our product candidates before we can apply for marketing approval.

Even if we complete our clinical trials, it does not assure

marketing approval.

Our pre-clinical trials may be unsuccessful, which would materially harm our business.

Even if our initial

pre-clinical trials are successful, we are required to conduct clinical trials to establish our product candidates’

and efficacy, before a marketing application (NDA or BLA or their foreign equivalents) can be filed with the FDA, the EMA, or comparable

foreign regulatory authorities for marketing approval of our product candidates.

Clinical testing is expensive, is difficult

to design and implement, can take many years to complete and is uncertain as to outcome.

Success in early phases of pre-clinical

and clinical trials does not ensure that later clinical trials will be successful, and interim results of a clinical trial do not

necessarily predict final results.

A failure of one or more of our clinical trials can occur at any stage of testing.

We may experience

numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent our ability to receive

regulatory approval or commercialize our product candidates.

The research, testing, manufacturing, labeling, packaging, storage,

approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject to

extensive regulation by the FDA, EMA, and other regulatory authorities in the United States, European Union, and other countries,

where regulations differ from country to country.

We are not permitted to market our product candidates as prescription pharmaceutical

products in the United States until we receive approval of an NDA from the FDA, or in any foreign countries until we receive the

requisite approval from such countries.

In the United States, the FDA generally requires the completion of clinical trials of each

drug to establish its safety and efficacy and extensive pharmaceutical development to ensure its quality before an NDA is approved.

Regulatory authorities in other jurisdictions impose similar requirements.

the large number of drugs in development, only a small percentage result in the submission of an NDA to the FDA or other regulatory

authorities and even fewer are eventually approved for commercialization.

We have not submitted an NDA to the FDA or comparable

applications to other regulatory authorities.

If our development efforts for our product candidates, including regulatory approval,

are not successful for their planned indications, or if adequate demand for our product candidates is not generated, our business

will be materially adversely affected.

success depends on the receipt of regulatory approval and the issuance of such regulatory approvals is uncertain and subject to

a number of risks, including the following:

results of nonclinical or toxicology studies may not support the filing of an IND or foreign equivalent for our product candidates;

FDA, EMA, or comparable foreign regulatory authorities or IRBs or ECs may disagree with the design or implementation of our

clinical trials;

may not be able to provide acceptable evidence of our product candidates’

Of the large number of drugs in development, only a

small percentage result in the submission of an NDA to the FDA or other regulatory authorities and even fewer are eventually approved

for commercialization.

We have not submitted an NDA to the FDA or comparable applications to other regulatory authorities.

development efforts for our product candidates, including regulatory approval, are not successful for their planned indications,

or if adequate demand for our product candidates is not generated, our business will be materially adversely affected.

Our success depends on the receipt of regulatory

approval and the issuance of such regulatory approvals is uncertain and subject to a number of risks, including the following:

the results of nonclinical or toxicology studies may not support the filing of an IND or foreign equivalent for our product candidates;

the FDA, EMA, or comparable foreign regulatory authorities or IRBs or ECs may disagree with the design or implementation of our clinical trials;

we may not be able to provide acceptable evidence of our product candidates’

safety and efficacy;

results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required

by the FDA, EMA, or other regulatory agencies for marketing approval;

dosing of our product candidates in a particular clinical trial may not be at an optimal level;

in our clinical trials may suffer adverse effects for reasons that may or may not be related to our product candidates;

data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA or other marketing application

or to obtain regulatory approval in the United States or elsewhere;

requirement for additional studies;

FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party

manufacturers with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in

a manner rendering our clinical data insufficient for approval;

FDA, EMA, or comparable foreign regulatory authorities may disagree on the design or implementation of our clinical trials,

including the methodology used in our studies, our chosen endpoints, our statistical analysis, or our proposed product indication;

failure to demonstrate to the satisfaction of the FDA, EMA, or comparable regulatory authorities that a product candidate

is safe and effective for its proposed indication;

may fail to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

immunogenicity

might affect a product candidate efficacy and/or safety;

FDA, EMA, or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies

or clinical trials;

collected from clinical trials of our product candidates may be insufficient to support the submission and filing of a marketing

application or to obtain marketing approval.

For example, the FDA may require additional studies to show that our product

candidates are safe or effective;

may fail to obtain approval of the manufacturing processes or facilities of third-party manufacturers with whom we contract

for clinical and commercial supplies;

may be changes in the approval policies or regulations that render our nonclinical and clinical data insufficient for approval;

FDA, EMA or comparable foreign regulatory authority may require more information, including additional nonclinical or clinical

data to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon

the development program.

to obtain regulatory approval for our product candidates for the foregoing, or any other reasons, will prevent us from commercializing

our product candidates, and our ability to generate revenue will be materially impaired.

We cannot guarantee that regulators will

agree with our assessment of the results of the clinical trials we intend to conduct in the future or that such trials will be

The FDA, EMA and other regulators have substantial discretion in the approval process and may refuse to accept any

application or may decide that our data is insufficient for approval and require additional clinical trials, or pre-clinical or

other studies.

In addition, varying interpretations of the data obtained from pre-clinical and clinical testing could delay, limit

or prevent regulatory approval of our product candidates.

have not submitted an IND or received regulatory approval to commence clinical trials for our product candidates in any jurisdiction.

We have only limited experience in filing the applications necessary to gain regulatory approvals and expect to rely on consultants

and third party CROs with expertise in this area to assist us in this process.

Securing regulatory approvals to market a product

requires the submission of pre-clinical, clinical, and/or pharmacokinetic data, information about product manufacturing processes

and inspection of facilities and supporting information to the appropriate regulatory authorities for each therapeutic indication

to establish a product candidate’s safety and efficacy for each indication.

Our product candidates may prove to have undesirable

or unintended side effects, toxicities or other characteristics that may preclude us from obtaining regulatory approval or prevent

or limit commercial use with respect to one or all intended indications.

process of obtaining regulatory approvals is expensive, often takes many years, if approval is obtained at all, and can vary substantially

based upon, among other things, the type, complexity and novelty of the product candidates involved, the jurisdiction in which

regulatory approval is sought and the substantial discretion of the regulatory authorities.

Changes in regulatory approval policies

during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review

for a submitted product application may cause delays in the approval or rejection of an application.

Regulatory approval obtained

in one jurisdiction does not necessarily mean that a product candidate will receive regulatory approval in all jurisdictions in

which we may seek approval, but the failure to obtain approval in one jurisdiction may negatively impact our ability to seek approval

in a different jurisdiction.

Failure to obtain regulatory marketing approval for our product candidates in any indication will

prevent us from commercializing the product candidate, and our ability to generate revenue will be materially impaired.

we are unable to submit an application for approval of BioLexa under Section 505(b)(2) of the FDCA or if we are required to generate

additional data related to the safety and efficacy of BioLexa in order to obtain approval under Section 505(b)(2), we may be unable

to meet our anticipated development and commercialization timelines.

current strategy for seeking marketing authorization in the United States of BioLexa relies primarily on Section 505(b)(2) of

the FDCA which permits use of a marketing application, referred to as a 505(b)(2) application, where at least some of the information

required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a

right of reference or use.

The FDA interprets this to mean that an applicant may rely for approval on such data as that found

in published literature or the FDA’s finding of safety or effectiveness, or both, of a previously approved drug product

owned by a third party.

There is no assurance that the FDA would find third-party data relied upon by us in a 505(b)(2) application

with respect to BioLexa sufficient or adequate to support approval and may require us to generate additional data to support the

safety and efficacy of BioLexa.

Consequently, we may need to conduct substantial new research and development activities beyond

those we currently plan to conduct.

the results of our clinical trials may not be satisfactory or may not meet the level of statistical or clinical significance required by the FDA, EMA, or other regulatory agencies for marketing approval;

the dosing of our product candidates in a particular clinical trial may not be at an optimal level;

patients in our clinical trials may suffer adverse effects for reasons that may or may not be related to our product candidates;

the data collected from clinical trials may not be sufficient to support the submission of an NDA, BLA or other marketing application or to obtain regulatory approval in the United States or elsewhere;

the requirement for additional studies;

the FDA, EMA, or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;

the approval policies or regulations of the FDA, EMA, or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval;

the FDA, EMA, or comparable foreign regulatory authorities may disagree on the design or implementation of our clinical trials, including the methodology used in our studies, our chosen endpoints, our statistical analysis, or our proposed product indication;

our failure to demonstrate to the satisfaction of the FDA, EMA, or comparable regulatory authorities that a product candidate is safe and effective for its proposed indication;

we may fail to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

immunogenicity might affect a product candidate’s efficacy and/or safety;

the FDA, EMA, or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;

data collected from clinical trials of our product candidates may be insufficient to support the submission and filing of a marketing application or to obtain marketing approval.

For example, the FDA may require additional studies to show that our product candidates are safe or effective;

we may fail to obtain approval of the manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies;

there may be changes in the approval policies or regulations that render our nonclinical and clinical data insufficient for approval;

the FDA, EMA or comparable foreign regulatory authority may require more information, including additional nonclinical or clinical data to support approval, which may delay or prevent approval and our commercialization plans, or we may decide to abandon the development program.

Failure to obtain regulatory approval for our

product candidates for the foregoing, or any other reasons, will prevent us from commercializing our product candidates, and our

ability to generate revenue will be materially impaired.

We cannot guarantee that regulators will agree with our assessment of

the results of the clinical trials we intend to conduct in the future or that such trials will be successful.

The FDA, EMA and

other regulators have substantial discretion in the approval process and may refuse to accept any application or may decide that

our data is insufficient for approval and require additional clinical trials, or pre-clinical or other studies.

In addition, varying

interpretations of the data obtained from pre-clinical and clinical testing could delay, limit or prevent regulatory approval of

our product candidates.

We have only limited experience in filing the

applications necessary to gain regulatory approvals and expect to rely on consultants and third party CROs with expertise in this

area to assist us in this process.

Securing regulatory approvals to market a product requires the submission of pre-clinical, clinical,

and/or pharmacokinetic data, information about product manufacturing processes and inspection of facilities and supporting information

to the appropriate regulatory authorities for each therapeutic indication to establish a product candidate’s safety and efficacy

for each indication.

Our product candidates may prove to have undesirable or unintended side effects, toxicities or other characteristics

that may preclude us from obtaining regulatory approval or prevent or limit commercial use with respect to one or all intended

The process of obtaining regulatory approvals

is expensive, often takes many years, if approval is obtained at all, and can vary substantially based upon, among other things,

the type, complexity and novelty of the product candidates involved, the jurisdiction in which regulatory approval is sought and

the substantial discretion of the regulatory authorities.

Changes in regulatory approval policies during the development period,

changes in or the enactment of additional statutes or regulations, or changes in regulatory review for a submitted product application

may cause delays in the approval or rejection of an application.

Regulatory approval obtained in one jurisdiction does not necessarily

mean that a product candidate will receive regulatory approval in all jurisdictions in which we may seek approval, but the failure

to obtain approval in one jurisdiction may negatively impact our ability to seek approval in a different jurisdiction.

to obtain regulatory marketing approval for our product candidates in any indication will prevent us from commercializing our product

candidates, and our ability to generate revenue will be materially impaired.

If we are unable to submit an application

for product candidate approval under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to

the safety and efficacy of a product candidate in order to obtain approval under Section 505(b)(2), we may be unable to meet our

anticipated development and commercialization timelines.

We may seek marketing authorization in the

United States under Section 505(b)(2) of the FDCA which permits use of a marketing application, referred to as a 505(b)(2) application,

where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which

the applicant has not obtained a right of reference or use.

The FDA interprets this to mean that an applicant may rely for approval

on such data as that found in published literature or the FDA’s finding of safety or effectiveness, or both, of a previously

approved drug product owned by a third party.

There is no assurance that the FDA would find third-party data relied upon by us

in a 505(b)(2) application sufficient or adequate to support approval and may require us to generate additional data to support

the safety and efficacy of a product candidate.

Consequently, we may need to conduct substantial new research and development activities

beyond those we currently plan to conduct.

Such additional new research and development activities would be costly and time consuming

and there is no assurance that such data generated from such additional activities would be sufficient to obtain approval.

the data to be relied upon in a 505(b)(2) application is related to drug products previously approved by the FDA and covered by

patents that are listed in the FDA’s Orange Book, we would be required to submit with our 505(b)(2) application a Paragraph

IV Certification in which we must certify that we do not infringe the listed patents or that such patents are invalid or unenforceable,

and provide notice to the patent owner or the holder of the approved NDA.

The patent owner or NDA holder would have 45 days from

receipt of the notification of our Paragraph IV Certification to initiate a patent infringement action against us.

If an infringement

action is initiated, the approval of our NDA would be subject to a stay of up to 30 months or more while we defend against such

Approval of our product candidates under Section 505(b)(2) may therefore be delayed until patent exclusivity expires or

until we successfully challenge the applicability of those patents to our product candidates.

Alternatively, we may elect to generate

sufficient clinical data so that we would no longer need to rely on third-party data, which would be costly and time consuming

and there would be no assurance that such data generated from such additional activities would be sufficient to obtain approval.

may not be able to obtain shortened review of our applications, and the FDA may not agree that BioLexa qualifies for marketing

If we are required to generate additional data to support approval, we may be unable to meet anticipated or reasonable

development and commercialization timelines, may be unable to generate the additional data at a reasonable cost, or at all, and

may be unable to obtain marketing approval of BioLexa.

If the FDA changes its interpretation of Section 505(b)(2) allowing reliance

on data in a previously approved drug application owned by a third party, or there is a change in the law affecting Section 505(b)(2),

this could delay or even prevent the FDA from approving any Section 505(b)(2) application that we submit.

Modifications

to our products may require new NDA approvals.

a particular product receives FDA approval or clearance, expanded uses or uses in new indications of our products may require

additional human clinical trials and new regulatory approvals or clearances, including additional IND and NDA submissions and

premarket approvals before we can begin clinical development, and/or prior to marketing and sales.

If the FDA requires new clearances

or approvals for a particular use or indication, we may be required to conduct additional clinical studies, which would require

additional expenditures and harm our operating results.

If the products are already being used for these new indications, we may

also be subject to significant enforcement actions.

Conducting clinical trials and obtaining clearances and approvals can be a

time consuming process, and delays in obtaining required future clearances or approvals could adversely affect our ability to

introduce new or enhanced products in a timely manner, which in turn would harm our future growth.

successful clinical studies may require the enrollment of large numbers of patients, and suitable patients may be difficult to

identify and recruit.

enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size

of the patient population;

the nature of the trial protocol;

the attractiveness of, or the discomforts and risks associated with,

the treatments received by enrolled subjects;

If the data to be relied upon in a 505(b)(2)

application is related to drug products previously approved by the FDA and covered by patents that are listed in the FDA’s

Orange Book, we would be required to submit with our 505(b)(2) application a Paragraph IV Certification in which we must certify

that we do not infringe the listed patents or that such patents are invalid or unenforceable, and provide notice to the patent

owner or the holder of the approved NDA.

The patent owner or NDA holder would have 45 days from receipt of the notification of

our Paragraph IV Certification to initiate a patent infringement action against us.

If an infringement action is initiated, the

approval of our NDA would be subject to a stay of up to 30 months or more while we defend against such a suit.

Approval of our

product candidates under Section 505(b)(2) may therefore be delayed until patent exclusivity expires or until we successfully challenge

the applicability of those patents to our product candidates.

Alternatively, we may elect to generate sufficient clinical data

so that we would no longer need to rely on third-party data, which would be costly and time consuming and there would be no assurance

that such data generated from such additional activities would be sufficient to obtain approval.

We may not be able to obtain shortened review

of our applications, and the FDA may not agree that a product candidate qualifies for marketing approval.

If we are required to

generate additional data to support approval, we may be unable to meet anticipated or reasonable development and commercialization

timelines, may be unable to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing

If the FDA changes its interpretation of Section 505(b)(2) allowing reliance on data in a previously approved drug application

owned by a third party, or there is a change in the law affecting Section 505(b)(2), this could delay or even prevent the FDA from

approving any Section 505(b)(2) application that we submit.

Modifications to our products may require

new drug or device approvals.

Once a particular product receives FDA approval

or clearance, expanded uses or uses in new indications of our products may require additional human clinical trials and new regulatory

approvals or clearances, including additional IND and NDA/BLA submissions or premarket approvals before we can begin clinical development,

and/or prior to marketing and sales.

If the FDA requires new clearances or approvals for a particular use or indication, we may

be required to conduct additional clinical studies, which would require additional expenditures and harm our operating results.

If the products are already being used for these new indications, we may also be subject to significant enforcement actions.

clinical trials and obtaining clearances and approvals can be a time consuming process, and delays in obtaining required future

clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn

would harm our future growth.

Conducting successful clinical studies

may require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit.

Patient enrollment in clinical trials and completion

of patient participation and follow-up depends on many factors, including the size of the patient population;

the nature of the

trial protocol;

the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects;

the availability of appropriate clinical trial investigators;

support staff;

proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in

the clinical trial and patient compliance.

For example, patients may be discouraged from enrolling in our clinical trials if the

trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness

of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable

risks or discomforts.

Patients may also not participate in our clinical trials if they choose to participate in contemporaneous

clinical trials of competitive products.

delays to the completion of clinical studies may result from modifications being made to the protocol during the clinical trial,

if such modifications are warranted and/or required by the occurrences in the given trial .

modification to the protocol during a clinical trial has to be submitted to the FDA.

This could result in the delay or halt of

a clinical trial while the modification is evaluated.

In addition, depending on the quantity and nature of the changes made, the

FDA could take the position that the data generated by the clinical trial is not poolable because the same protocol was not used

throughout the trial.

This might require the enrollment of additional subjects, which could result in the extension of the clinical

trial and the FDA delaying clearance or approval of a product.

Any such delay could have a material adverse effect on our business

and results of operations.

can be no assurance that the data generated from our clinical trials using modified protocols will be acceptable to FDA.

can be no assurance that the data generated using modified protocols will be acceptable to the FDA or that if future modifications

during the trial are necessary, that any such modifications will be acceptable to the FDA.

If the FDA believes that its prior

approval is required for a particular modification, it can delay or halt a clinical trial while it evaluates additional information

regarding the change.

injury or death resulting from a failure of one of our drug candidates during current or future clinical trials could also result

in the FDA delaying our clinical trials or denying or delaying clearance or approval of a product.

though an adverse event may not be the result of the failure of our drug candidate, the FDA or an IRB could delay or halt a clinical

trial for an indefinite period of time while an adverse event is reviewed, and likely would do so in the event of multiple such

delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining

or maintaining required approvals from IRBs, delays in patient enrollment, the failure of patients to continue to participate

in a clinical trial, and delays or termination of clinical trials as a result of protocol modifications or adverse events during

the trials, may cause an increase in costs and delays in the filing of any product submissions with the FDA, delay the approval

and commercialization of our products or result in the failure of the clinical trial, which could adversely affect our business,

operating results and prospects.

the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform

as contractually required or expected, we may not be able to obtain regulatory approval for or commercialize our products.

do not have the ability to independently conduct our pre-clinical and clinical trials for our products and we must rely on third

parties, such as CROs, medical institutions, clinical investigators and contract laboratories to conduct such trials.

third parties do not successfully carry out their contractual duties or regulatory obligations, meet expected deadlines or need

to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical

protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended,

delayed, suspended or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our

products on a timely basis, if at all.

Furthermore, our third-party clinical trial investigators may be delayed in conducting

our clinical trials for reasons outside of their control.

The occurrence of any of the foregoing may adversely affect our business,

operating results and prospects.

future results of our current or future clinical trials may not support our product candidate claims or may result in the discovery

of unexpected adverse side effects.

if our clinical trials are completed as planned, we cannot be certain that their results will support our drug candidate claims

or that the FDA or foreign authorities will agree with our conclusions regarding them.

Success in pre-clinical studies and early

clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will

replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our drug

candidates are safe and effective for the proposed indicated uses.

If the FDA concludes that the clinical trials for any product

for which we might seek clearance, has failed to demonstrate safety and effectiveness, we would not receive FDA clearance to market

that product in the United States for the indications sought.

addition, such an outcome could cause us to abandon the product candidate and might delay development of others.

termination of our clinical trials will delay the filing of any product submissions with the FDA and, ultimately, our ability

to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will

experience adverse side effects that are not currently part of the product candidate’s profile.

In addition, our clinical

trials for BioLexa involve a relatively small patient population.

Because of the small sample size, our results may not be indicative

of future results.

current and future products may never achieve market acceptance.

current and future products that we may develop may never gain market acceptance among physicians, patients and the medical community.

The degree of market acceptance of any of our products will depend on a number of factors, including the actual and perceived

effectiveness and reliability of our products;

the results of any long-term clinical trials relating to use of our products;

availability, relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments

using our products are approved for reimbursement by public and private insurers;

the willingness of patients to pay out of pocket

in the absence of government or third-party coverage;

the strength of our marketing and distribution infrastructure;

of education and awareness among physicians and hospitals concerning our products;

and prevalence and severity of any side effects.

Failure of our products to significantly penetrate current or new markets would negatively impact our business, financial condition

and results of operations.

be commercially successful, physicians must be persuaded that using our products are effective alternatives to existing therapies

and treatments.

believe that physicians will not widely adopt our products unless they determine, based on experience, clinical data, and published

peer-reviewed journal articles, that the use of our products provides an effective alternative to other means of treating dermatological

disorders/ailments, lupus or food allergies.

Patient studies or clinical experience may indicate that treatment with our products

does not provide patients with sufficient benefits in quality of life.

We believe that recommendations and support for the use

of our products from influential physicians will be essential for widespread market acceptance.

Our products are still in development

and it is premature to attempt to gain support from physicians at this time.

We can provide no assurance that such support will

ever be obtained.

If our products do not receive such support from these physicians and from long-term data, physicians may not

use or continue to use, and hospitals may not purchase or continue to purchase, our products.

if our products are approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulation or if

we experience unanticipated problems with our products, these products could be subject to restrictions or withdrawal from the

product for which we obtain clearance or approval, and the manufacturing processes, reporting requirements, post-approval clinical

data and promotional activities for such product, will be subject to continued regulatory review, oversight and periodic inspections

In particular, we and our suppliers are required to comply with FDA’s Quality System Regulations, or QSR, and

International Standards Organization, or ISO, regulations for the manufacture of our products and other regulations which cover

the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, storage and

shipping of any product for which we obtain clearance or approval.

Regulatory bodies, such as the FDA, enforce these regulations

through periodic inspections.

The failure by us or one of our suppliers to comply with applicable statutes and regulations administered

by the FDA and other regulatory bodies, or the failure to timely and adequately respond to any adverse inspectional observations

or product safety issues, could result in, among other things, enforcement actions by the FDA.

any of these actions were to occur it would harm our reputation and cause our product sales and profitability to suffer and may

prevent us from generating revenue.

Furthermore, our key component suppliers may not currently be or may not continue to be in

compliance with all applicable regulatory requirements which could result in our failure to produce our products on a timely basis

and in the required quantities, if at all.

if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended

uses for which the product may be marketed and reduce the potential to successfully commercialize the product and generate revenue

from the product.

If the FDA determines that the product promotional materials, labeling, training or other marketing or educational

activities constitute promotion of an unapproved use, it could request that we or our commercialization partners cease or modify

our training or promotional materials or subject us to regulatory enforcement actions.

It is also possible that other federal,

state or foreign enforcement authorities might take action if they consider such training or other promotional materials to constitute

promotion of an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as

laws prohibiting false claims for reimbursement.

addition, we may be required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of

our products, and we must comply with adverse event and pharmacovigilance reporting requirements, including the reporting of adverse

events which occur in connection with, and whether or not directly related to, our products.

Later discovery of previously unknown

problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing

problems, or failure to comply with regulatory requirements, may result in changes to labeling, restrictions on such products

or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to recall,

replace or refund the cost of any product we manufacture or distribute, fines, suspension of regulatory approvals, product seizures,

injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and

revenue stream will depend upon third-party reimbursement.

commercial success of our products in both domestic and international markets will be substantially dependent on whether third-party

coverage and reimbursement is available for patients that use our products.

However, the availability of insurance coverage and

reimbursement for newly approved therapies is uncertain, and therefore, third-party coverage may be particularly difficult to

obtain even if our products are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally

reimbursed all or part of the product cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations

and other third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of

reimbursement of new drugs, and, as a result, they may not cover or provide adequate payment for these products.

Submission of

applications for reimbursement approval generally does not occur prior to the filing of an NDA for that product and may not be

granted for as long as many months after NDA approval.

In order to obtain reimbursement arrangements for these products, we or

our commercialization partners may have to agree to a net sales price lower than the net sales price we might charge in other

sales channels.

The continuing efforts of government and third-party payors to contain or reduce the costs of healthcare may limit

Initial dependence on the commercial success of our products may make our revenues particularly susceptible to any

cost containment or reduction efforts.

will need to make additions to senior management in order to successfully execute our business plan.

Company will need to identify and recruit prospective executives with proven experience in the biopharmaceutical

industry, specifically candidates who have managed and completed FDA-required submissions and clinical trials concerning new products.

Knie, the acting Chief Executive Officer, is one of the founders and has agreed to serve in that capacity in the interim.

his primary background involves electronics and technology, he has experience in venture-level investments and early stage capital

formation for emerging growth companies.

The Company has entered into an employment agreement with Mr.

Knie which includes various

provisions that may result in significant financial and severance obligations to the Company.

Our inability to recruit and

retain executives with proven experience in the biopharmaceutical industry could delay or negatively affect our ability to execute

on our business plan, which would have a material adverse effect on our financial condition and results of operation.

and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product

candidates and affect the prices we may obtain for such product candidates.

the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed

changes regarding the healthcare system that could prevent or delay marketing approval for our product candidates, restrict or

regulate post-approval activities and affect our ability to profitably sell our product candidates.

Legislative and regulatory

proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical

We do not know whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations

will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be.

increased scrutiny by the U.S.

Congress of the FDA’s approval process may significantly delay or prevent marketing approval,

as well as subject us to more stringent product labeling and post-marketing testing and other requirements.

the United States, the Medicare Modernization Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical

The legislation expanded Medicare coverage for drug purchases by the elderly and introduced a new reimbursement methodology

based on average sales prices for drugs.

In addition, this legislation authorized Medicare Part D prescription drug plans to use

formularies where they can limit the number of drugs that will be covered in any therapeutic class.

As a result of this legislation

and the expansion of federal coverage of drug products, we expect that there will be additional pressure to contain and reduce

These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we

receive for our product candidates and could seriously harm our business.

While the MMA applies only to drug benefits for Medicare

beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement

rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010

(collectively, the “Health Care Reform Law”) is a sweeping law intended to broaden access to health insurance, reduce

or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for

healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy

The Health Care Reform Law revised the definition of “average manufacturer price”

for reporting purposes,

which could increase the amount of Medicaid drug rebates to states.

Further, the law imposed a significant annual fee on companies

that manufacture or import branded prescription drug products.

Health Care Reform Law remains subject to legislative efforts to repeal, modify or delay the implementation of the law.

if the Health Care Reform Law is repealed or modified, or if implementation of certain aspects of the Health Care Reform Law are

delayed, such repeal, modification or delay may materially adversely impact our business, strategies, prospects, operating results

or financial condition.

We are unable to predict the full impact of any repeal, modification or delay in the implementation of

the Health Care Reform Law on us at this time.

Due to the substantial regulatory changes that will need to be implemented by the

Centers for Medicare & Medicaid Services and others, and the numerous processes required to implement these reforms, we cannot

predict which healthcare initiatives will be implemented at the federal or state level, the timing of any such reforms, or the

effect such reforms or any other future legislation or regulation will have on our business.

addition, other legislative changes have been proposed and adopted in the United States since the Health Care Reform Law was enacted.

We expect that additional federal healthcare reform measures will be adopted in the future, any of which could limit the amounts

that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected

value of certain development projects and reduce or eliminate our profitability.

are dependent on third parties for manufacturing and marketing of our proposed product candidates.

If we are not able to secure

favorable arrangements with such third parties, our business and financial condition could be harmed.

will not manufacture any of our proposed product candidates for commercial sale nor do we have the resources necessary to do so.

In addition, we currently do not have the capability to market our drug products ourselves.

In addition to our internal sales

force efforts, we intend to contract with specialized manufacturing companies to manufacture our proposed product candidates and

partner with larger pharmaceutical companies for commercialization of our products.

In connection with our efforts to commercialize

our proposed product candidates, we will seek to secure favorable arrangements with third parties to distribute, promote, market

and sell our proposed product candidates.

If our internal sales force is unable to successfully distribute, market and promote

our product candidates and we are not able to secure favorable commercial terms or arrangements with third parties for the distribution,

marketing, promotion and sales of our proposed product candidates, we may have to retain promotional and marketing rights and

seek to develop the commercial resources necessary to promote or co-promote or co-market certain or all of our proposed drug candidates

and proximity of patients to clinical sites;

to comply with the eligibility and exclusion criteria for participation in the clinical trial;

and patient compliance.

patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment

procedures or follow-up to assess the safety and effectiveness of our product candidates or if they determine that the treatments

received under the trial protocols are not attractive or involve unacceptable risks or discomforts.

Patients may also not participate

in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products.

Additional delays to the completion of

clinical studies may result from modifications being made to the protocol during the clinical trial, if such modifications are

warranted and/or required by the occurrences in the given trial .

Each modification to the protocol during a

clinical trial has to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the modification

is evaluated.

In addition, depending on the quantity and nature of the changes made, the FDA could take the position that the data

generated by the clinical trial is not poolable because the same protocol was not used throughout the trial.

This might require

the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying clearance

or approval of a product.

Any such delay could have a material adverse effect on our business and results of operations.

There can be no assurance that the data

generated from our clinical trials using modified protocols will be acceptable to FDA.

There can be no assurance that the data generated

using modified protocols will be acceptable to the FDA or that if future modifications during the trial are necessary, that any

such modifications will be acceptable to the FDA.

If the FDA believes that its prior approval is required for a particular modification,

it can delay or halt a clinical trial while it evaluates additional information regarding the change.

Serious injury or death resulting from a failure

of one of our drug candidates during clinical trials could also result in the FDA delaying our clinical trials or denying or delaying

clearance or approval of a product candidate.

Even though an adverse event may not be the result of the failure of our drug candidate,

the FDA or an IRB could delay or halt a clinical trial for an indefinite period of time while an adverse event is reviewed, and

likely would do so in the event of multiple such events.

Any delay or termination of our current or

future clinical trials as a result of the risks summarized above, including delays in obtaining or maintaining required approvals

from IRBs, delays in patient enrollment, the failure of patients to continue to participate in a clinical trial, and delays or

termination of clinical trials as a result of protocol modifications or adverse events during the trials, may cause an increase

in costs and delays in the filing of any product submissions with the FDA, delay the approval and commercialization of our products

or result in the failure of the clinical trial, which could adversely affect our business, operating results and prospects.

We rely on third parties to conduct our

clinical trials and to assist us with pre-clinical development.

If these third parties do not perform as contractually required

or expected, we may not be able to obtain regulatory approval for or commercialize our products.

We do not have the ability to independently

conduct our pre-clinical and clinical trials for our product candidates, and we must rely on third parties, such as CROs, medical

institutions, clinical investigators and contract laboratories to conduct such trials.

If these third parties do not successfully

carry out their contractual duties or regulatory obligations, meet expected deadlines or need to be replaced, or if the quality

or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements

or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated,

and we may not be able to obtain regulatory approval for, or successfully commercialize, our products on a timely basis, if at

Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside

of their control.

The occurrence of any of the foregoing may adversely affect our business, operating results and prospects.

The future results of our current or

future clinical trials may not support our product candidate claims or may result in the discovery of unexpected adverse side effects.

Even if our clinical trials are completed as

planned, we cannot be certain that their results will support our drug candidate claims or that the FDA or foreign regulatory agencies

will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical trials does not ensure that

later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials

and pre-clinical studies.

The clinical trial process may fail to demonstrate that our drug candidates are safe and effective for

the proposed indicated uses.

If the FDA or other regulatory agencies conclude that the clinical trials for any of our product candidates

has failed to demonstrate safety and effectiveness, we would not receive clearance from the FDA or other regulatory agencies to

market that product in the United States or internationally for the indications sought.

In addition, such an outcome could cause us

to abandon the product candidate and might delay development of other product candidates.

Any delay or termination of our clinical

trials will delay the filing of any product submissions with the FDA and, ultimately, our ability to commercialize our product

candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience adverse side effects

that are not currently part of the product candidate’s profile.

In addition, our clinical trials may involve a relatively

small patient population.

Because of the small sample size, our results may not be indicative of future results.

Even if our product candidates are approved

by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA regulations or if we experience unanticipated

problems with our products, these products could be subject to restrictions or withdrawal from the market.

The manufacturing processes, reporting requirements,

post-approval clinical data and promotional activities for any product candidate for which we obtain regulatory approval will be

subject to continued regulatory review, oversight and periodic inspections by the FDA.

In particular, we and our suppliers are

required to comply with FDA’s Quality System Regulations and International Standards Organization (“ISO”) regulations

for the manufacture of our products and other regulations which cover the methods and documentation of the design, testing, production,

control, quality assurance, labeling, packaging, storage and shipping of any product for which we obtain clearance or approval.

Regulatory bodies, such as the FDA, enforce these regulations through periodic inspections.

The failure by us or one of our suppliers

to comply with applicable statutes and regulations administered by the FDA and other regulatory bodies, or the failure to timely

and adequately respond to any adverse inspectional observations or product safety issues, could result in, among other things,

enforcement actions by the FDA.

If any of these actions were to occur it would

harm our reputation and cause our product sales and profitability to suffer and may prevent us from generating revenue.

our key component suppliers may not currently be or may not continue to be in compliance with all applicable regulatory requirements

which could result in our failure to produce our products on a timely basis and in the required quantities, if at all.

Even if regulatory clearance or approval of

a product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be

marketed and reduce the potential to successfully commercialize the product and generate revenue from the product.

If the FDA determines

that the product promotional materials, labeling, training or other marketing or educational activities constitute promotion of

an unapproved use, it could request that we or our commercialization partners cease or modify our training or promotional materials

or subject us to regulatory enforcement actions.

It is also possible that other federal, state or foreign enforcement authorities

might take action if they consider such training or other promotional materials to constitute promotion of an unapproved use, which

could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

In addition, we may be required to conduct

costly post-market testing and surveillance to monitor the safety or effectiveness of our products, and we must comply with adverse

event and pharmacovigilance reporting requirements, including the reporting of adverse events which occur in connection with, and

whether or not directly related to, our products.

Later discovery of previously unknown problems with our products, including unanticipated

adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory

requirements, may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products

from the market, voluntary or mandatory recalls, a requirement to recall, replace or refund the cost of any product we manufacture

or distribute, fines, suspension of regulatory approvals, product seizures, injunctions or the imposition of civil or criminal

penalties which would adversely affect our business, operating results and prospects.

Our revenue stream will depend upon third-party

reimbursement.

The commercial success of our products in both

domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement is available

for patients that use our products.

However, the availability of insurance coverage and reimbursement for newly approved therapies

is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products are approved by

the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part of the product

cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party payors

are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs,

and, as a result, they may not cover or provide adequate payment for these products.

Submission of applications for reimbursement

approval generally does not occur prior to the filing of an NDA for that product and may not be granted for as long as many months

after NDA approval.

In order to obtain reimbursement arrangements for these products, we or our commercialization partners may

have to agree to a net sales price lower than the net sales price we might charge in other sales channels.

The continuing efforts

of government and third-party payors to contain or reduce the costs of healthcare may limit our revenue.

Initial dependence on

the commercial success of our products may make our revenues particularly susceptible to any cost containment or reduction efforts.

Current and future legislation may increase

the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we

may obtain for such product candidates.

In the United States and some foreign jurisdictions,

there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could

prevent or delay marketing approval for our product candidates, restrict or regulate post-approval activities and affect our ability

to profitably sell our product candidates.

Legislative and regulatory proposals have been made to expand post-approval requirements

and restrict sales and promotional activities for pharmaceutical products.

We do not know whether additional legislative changes

will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes

on the marketing approvals of our product candidates, if any, may be.

In addition, increased scrutiny by the U.S.

Congress of the

FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent product

labeling and post-marketing testing and other requirements.

In the United States, the Medicare Modernization

Act (“MMA”) changed the way Medicare covers and pays for pharmaceutical products.

The legislation expanded Medicare

coverage for drug purchases by the elderly and introduced a new reimbursement methodology based on average sales prices for drugs.

In addition, this legislation authorized Medicare Part D prescription drug plans to use formularies where they can limit the number

of drugs that will be covered in any therapeutic class.

As a result of this legislation and the expansion of federal coverage of

drug products, we expect that there will be additional pressure to contain and reduce costs.

These cost reduction initiatives and

other provisions of this legislation could decrease the coverage and price that we receive for our product candidates and could

seriously harm our business.

While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow

Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that

results from the MMA may result in a similar reduction in payments from private payors.

The Patient Protection and Affordable Care

Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Health Care

Reform Law”) is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare

spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries,

impose new taxes and fees on the health industry and impose additional health policy reforms.

The Health Care Reform Law revised

the definition of “average manufacturer price”

for reporting purposes, which could increase the amount of Medicaid

drug rebates to states.

Further, the law imposed a significant annual fee on companies that manufacture or import branded prescription

drug products.

The Health Care Reform Law remains subject

to legislative efforts to repeal, modify or delay the implementation of the law.

However, if the Health Care Reform Law is repealed

or modified, or if implementation of certain aspects of the Health Care Reform Law are delayed, such repeal, modification or delay

may materially adversely impact our business, strategies, prospects, operating results or financial condition.

We are unable to

predict the full impact of any repeal, modification or delay in the implementation of the Health Care Reform Law on us at this

Due to the substantial regulatory changes that will need to be implemented by the Centers for Medicare & Medicaid

Services and others, and the numerous processes required to implement these reforms, we cannot predict which healthcare initiatives

will be implemented at the federal or state level, the timing of any such reforms, or the effect such reforms or any other future

legislation or regulation will have on our business.

In addition, other legislative changes have

been proposed and adopted in the United States since the Health Care Reform Law was enacted.

We expect that additional federal

healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments

will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain development

projects and reduce or eliminate our profitability.

We are dependent on third parties for

manufacturing and marketing of our proposed product candidates.

If we are not able to secure favorable arrangements with such third

parties, our business and financial condition could be harmed.

We will not manufacture any of our proposed

product candidates for commercial sale nor do we have the resources necessary to do so.

In addition, we currently do not have the

capability to market our drug products ourselves.

In addition to our internal sales force efforts, we have contracted with and

intend to continue to contract with specialized manufacturing companies to manufacture our proposed product candidates and partner

with larger pharmaceutical companies for commercialization of our products.

In connection with our efforts to commercialize our

proposed product candidates, we will seek to secure favorable arrangements with third parties to distribute, promote, market and

sell our proposed product candidates.

If our internal sales force is unable to successfully distribute, market and promote our

product candidates and we are not able to secure favorable commercial terms or arrangements with third parties for the distribution,

marketing, promotion and sales of our proposed product candidates, we may have to retain promotional and marketing rights and seek

to develop the commercial resources necessary to promote or co-promote or co-market certain or all of our proposed drug candidates

to the appropriate channels of distribution in order to reach the specific medical market that we are targeting.

8 unchanged sentences

Any increase in the number of our employees would increase our expense level, and could have an adverse effect on our financial

addition, we, or our potential commercial partners, may not successfully introduce our proposed product candidates or such candidates

may not achieve acceptance by patients, health care providers and insurance companies.

Further, it is possible that we may not

be able to secure arrangements to manufacture, market, distribute, promote and sell our proposed product candidates at favorable

commercial terms that would permit us to make a profit.

To the extent that corporate partners conduct clinical trials, we may

not be able to control the design and conduct of these clinical trials.

may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.

may have conflicts with our partners, such as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement

of milestones, the interpretation of contractual obligations, payments for services, development obligations or the ownership

of intellectual property developed during our collaboration.

If any conflicts arise with any of our partners, such partner may

act in a manner that is adverse to our best interests.

Any such disagreement could result in one or more of the following, each

of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating

unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent

us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of

the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep us informed

regarding the progress of its development and commercialization activities or to permit public disclosure of the results of those

initiating of litigation or alternative dispute resolution options by either party to resolve the dispute;

by either party to terminate the agreement.

if we receive regulatory approval for any of our product candidates, we may not be able to successfully commercialize the product

and the revenue that we generate from its sales, if any, may be limited.

approved for marketing, the commercial success of our product candidates will depend upon each product’s acceptance by the

medical community, including physicians, patients and health care payors.

The degree of market acceptance for any of our product

candidates will depend on a number of factors, including:

demonstration

of clinical safety and efficacy;

convenience, dosing burden and ease of administration;

prevalence and severity of any adverse effects;

willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;

of our product candidates compared to competing products;

introduction of any new products that may in the future become available targeting indications for which our product candidates

may be approved;

procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show

and cost-effectiveness;

inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;

effectiveness of our own or any future collaborators’

In addition, we, or our potential commercial

partners, may not successfully introduce our proposed product candidates or such candidates may not achieve acceptance by patients,

health care providers and insurance companies.

Further, it is possible that we may not be able to secure arrangements to manufacture,

market, distribute, promote and sell our proposed product candidates at favorable commercial terms that would permit us to make

To the extent that corporate partners conduct clinical trials, we may not be able to control the design and conduct of

these clinical trials.

We may have conflicts with our partners

that could delay or prevent the development or commercialization of our product candidates.

We may have conflicts with our partners, such

as conflicts concerning the interpretation of pre-clinical or clinical data, the achievement of milestones, the interpretation

of contractual obligations, payments for services, development obligations or the ownership of intellectual property developed

during our collaboration.

If any conflicts arise with any of our partners, such partner may act in a manner that is adverse to

our best interests.

Any such disagreement could result in one or more of the following, each of which could delay or prevent the

development or commercialization of our product candidates, and in turn prevent us from generating revenues:

unwillingness on the

part of a partner to pay us milestone payments or royalties we believe are due to us under a collaboration;

uncertainty regarding

ownership of intellectual property rights arising from our collaborative activities, which could prevent us from entering into

additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product, including

providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress

of its development and commercialization activities or to permit public disclosure of the results of those activities;

of litigation or alternative dispute resolution options by either party to resolve the dispute;

or attempts by either party to

terminate the agreement.

Even if we receive regulatory approval

for any of our product candidates, we may not be able to successfully commercialize the product and the revenue that we generate

from its sales, if any, may be limited.

If approved for marketing, the commercial success

of our product candidates will depend upon each product’s acceptance by the medical community, including physicians, patients

and health care payors.

The degree of market acceptance for any of our product candidates will depend on a number of factors, including:

demonstration of clinical safety and efficacy;

relative convenience, dosing burden and ease of administration;

the prevalence and severity of any adverse effects;

the willingness of physicians to prescribe our product candidates, and the target patient population to try new therapies;

efficacy of our product candidates compared to competing products;

the introduction of any new products that may in the future become available targeting indications for which our product candidates may be approved;

new procedures or therapies that may reduce the incidences of any of the indications in which our product candidates may show utility;

pricing and cost-effectiveness;

the inclusion or omission of our product candidates in applicable therapeutic and vaccine guidelines;

the effectiveness of our own or any future collaborators’

sales and marketing strategies;

or warnings contained in approved labeling from regulatory authorities;

ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including

Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals

from government bodies regulating the pricing and usage of therapeutics;

willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing

any of our product candidates are approved, but do not achieve an adequate level of acceptance by physicians, health care payors,

and patients, we may not generate sufficient revenue and we may not be able to achieve or sustain profitability.

Our efforts to

educate the medical community and third-party payors on the benefits of our product candidates may require significant resources

and may never be successful.

addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize

our product candidates successfully.

For example, if the approval process takes too long, we may miss market opportunities and

give other companies the ability to develop competing products or establish market dominance.

Any regulatory approval we ultimately

obtain may be limited or subject to restrictions or post-approval commitments that render our product candidates not commercially

For example, regulatory authorities may approve any of our product candidates for fewer or more limited indications than

we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve any of our

product candidates with a label that does not include the labeling claims necessary or desirable for the successful commercialization

for that indication.

Further, the FDA or comparable foreign regulatory authorities may place conditions on approvals or require

risk management plans or a REMS to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the

NDA must submit a proposed REMS;

limitations or warnings contained in approved labeling from regulatory authorities;

our ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid, private health insurers and other third-party payors or to receive the necessary pricing approvals from government bodies regulating the pricing and usage of therapeutics;

the willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement or government pricing approvals.

If any of our product candidates are approved,

but do not achieve an adequate level of acceptance by physicians, health care payors, and patients, we may not generate sufficient

revenue and we may not be able to achieve or sustain profitability.

Our efforts to educate the medical community and third-party

payors on the benefits of our product candidates may require significant resources and may never be successful.

In addition, even if we obtain regulatory approvals,

the timing or scope of any approvals may prohibit or reduce our ability to commercialize our product candidates successfully.

example, if the approval process takes too long, we may miss market opportunities thereby giving other companies the ability to

develop competing products or establish market dominance.

Any regulatory approval we ultimately obtain may be limited or subject

to restrictions or post-approval commitments that render our product candidates not commercially viable.

For example, regulatory

authorities may approve any of our product candidates for fewer or more limited indications than we request, may grant approval

contingent on the performance of costly post-marketing clinical trials, or may approve any of our product candidates with a label

that does not include the labeling claims necessary or desirable for the successful commercialization for that indication.

the FDA or comparable foreign regulatory authorities may place conditions on approvals or require risk management plans or a REMS

to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the NDA must submit a proposed REMS.

The FDA will not approve the NDA without an approved REMS, if required.

A REMS could include

medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient

registries and other risk minimization tools.

The FDA may also require a REMS for an approved product when new safety information

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription

or dispensing of our product candidates.

Moreover, product approvals may be withdrawn for non-compliance with regulatory standards

or if problems occur following the initial marketing of the product.

Any of the foregoing scenarios could materially harm the

commercial success of our product candidates.

commercialization of our products, we may be dependent on third parties to market, distribute and sell our products.

ability to receive revenues may be dependent upon the sales and marketing efforts of any future co-marketing partners and third-party

distributors.

At this time, we have not entered into an agreement with any commercialization partner and only plan to do so prior

to commercialization.

If we fail to reach an agreement with any commercialization partner, or upon reaching such an agreement

that partner fails to sell a large volume of our products, it may have a negative impact on our business, financial condition

and results of operations.

products will face significant competition in the markets for such products, and if they are unable to compete successfully, our

business will suffer.

product candidates face, and will continue to face, intense competition from large pharmaceutical companies, as well as academic

and research institutions.

We compete in an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry

standards, (iii) emerging competition and (iv) new product introductions.

Our competitors have existing products and technologies

that will compete with our products and technologies and may develop and commercialize additional products and technologies that

will compete with our products and technologies.

Because several competing companies and institutions have greater financial resources

than us, they may be able to:

(i) provide broader services and product lines, (ii) make greater investments in research and development

and (iii) carry on larger research and development initiatives.

Our competitors also have greater development capabilities than

we do and have substantially greater experience in undertaking pre-clinical and clinical testing of products, obtaining regulatory

approvals, and manufacturing and marketing pharmaceutical products.

They also have greater name recognition and better access

to customers than us.

Our chief competitors include companies such as Pfizer Inc.

and Sanofi S.A.

events involving our products may lead the FDA to delay or deny clearance for our products or result in product recalls that could

A REMS could include medication guides, physician communication

plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization

The FDA may also require a REMS for an approved product when new safety information emerges.

Any of these limitations on

approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of our product candidates.

Moreover, product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following the initial

marketing of the product.

Any of the foregoing scenarios could materially harm the commercial success of our product candidates.

The FDA’s policy with respect to Emergency Use Authorizations

is evolving and may limit the ability for medical products, including , to be eligible for commercialization under an Emergency

Use Authorization.

We intend to submit applications to FDA for

Emergency Use Authorization (“EUA”) for our COVID-19 products.

The FDA has the authority to grant an EUA to allow

unapproved medical products to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions

during the COVID-19 public health emergency.

If we are granted an EUA for our COVID-19 products, we would be able to commercialize

the products prior to FDA clearance or approval.

However, the FDA does not have review deadlines with respect to such submissions

and, therefore, the timing of any approval of an EUA submission is uncertain.

We cannot guarantee that the FDA will review our

data in a timely manner, or that the FDA will accept the data when reviewed.

The FDA may decide that our data are insufficient

for an EUA and require additional pre-clinical, clinical or other studies and refuse to approve our application.

the FDA may revoke an EUA where it is determined that the public health emergency no longer exists or warrants such authorization,

and therefore we cannot predict how long any authorized EUA would remain in place.

Further, the FDA’s policy with respect

to EUAs related to COVID-19 is evolving and may in the future limit the ability for medical products, including our products,

to be eligible for an EUA.

Our products will face significant competition,

and if they are unable to compete successfully, our business will suffer.

Our product candidates face, and will continue

to face, intense competition from large pharmaceutical companies, as well as academic and research institutions.

We compete in

an industry that is characterized by:

(i) rapid technological change, (ii) evolving industry standards, (iii) emerging competition

and (iv) new product introductions.

Our competitors have and may develop products and technologies that will compete with our products

and technologies.

Because several competing companies and institutions have greater financial resources than us, they may be able

(i) provide broader services and product lines, (ii) make greater investments in research and development and (iii) carry on

larger research and development initiatives.

Our competitors also have greater development capabilities than we do and have substantially

greater experience in undertaking pre-clinical and clinical testing of products, obtaining regulatory approvals, and manufacturing

and marketing pharmaceutical products.

They also have greater name recognition and better access to customers than us.

Adverse events involving our products

may lead the FDA or other regulatory agencies to delay or deny clearance for our products or result in product recalls that could

harm our reputation, business and financial results.

a product receives FDA clearance or approval, the agency has the authority to require the recall of commercialized products in

the event of adverse side effects, material deficiencies or defects in design or manufacture.

The authority to require a recall

must be based on an FDA finding that there is a reasonable probability that the product would cause serious injury or death.

Manufacturers

may, under their own initiative, recall a product if any material deficiency in a product is found.

A government-mandated or voluntary

recall by us or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination,

manufacturing errors, design or labeling defects or other deficiencies and issues.

Recalls of any of our products would divert

managerial and financial resources and have an adverse effect on our financial condition and results of operations.

The FDA requires

Once a product receives clearance or approval,

the agency has the authority to require the recall of commercialized products in the event of adverse side effects, material deficiencies

or defects in design or manufacture.

With respect to the FDA, the authority to require a recall must be based on an FDA finding

that there is a reasonable probability that the product would cause serious injury or death.

Manufacturers may, under their own

initiative, recall a product if any material deficiency in a product is found.

A government-mandated or voluntary recall by us

or one of our distributors could occur as a result of adverse side effects, impurities or other product contamination, manufacturing

errors, design or labeling defects or other deficiencies and issues.

Recalls of any of our products would divert managerial and

financial resources and have an adverse effect on our financial condition and results of operations.

In addition, the FDA requires

that certain classifications of recalls be reported to FDA within ten working days after the recall is initiated.

9 unchanged sentences

were conducted.

we fail to comply with healthcare regulations, we could face substantial enforcement actions, including civil and criminal penalties

and our business, operations and financial condition could be adversely affected.

could be subject to healthcare fraud and abuse laws and patient privacy laws of both the federal government and the states in

which we conduct our business.

If we fail to comply with healthcare

regulations, we could face substantial enforcement actions, including civil and criminal penalties and our business, operations

and financial condition could be adversely affected.

We could be subject to healthcare fraud and

abuse laws and patient privacy laws of both the federal government and the states in which we conduct our business.

The laws include:

federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing

remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing

or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and

Medicaid programs;

false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be

presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which

may apply to entities like us which provide coding and billing information to customers;

federal Health Insurance Portability and Accountability Act of 1996, which prohibits executing a scheme to defraud any healthcare

benefit program or making false statements relating to healthcare matters and which also imposes certain requirements relating

to the privacy, security and transmission of individually identifiable health information;

FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing

drug products for off-label use and regulates the distribution of drug samples;

law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or

services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security

of health information in certain circumstances, many of which differ from each other in significant ways and often are not

preempted by federal laws, thus complicating compliance efforts.

our operations are found to be in violation of any of the laws described above or any governmental regulations that apply to us,

we may be subject to penalties, including civil and criminal penalties, damages, fines and the curtailment or restructuring of

our operations.

Any penalties, damages, fines, curtailment or restructuring of our operations could adversely affect our ability

to operate our business and our financial results.

Although compliance programs can mitigate the risk of investigation and prosecution

for violations of these laws, the risks cannot be entirely eliminated.

Any action against us for violation of these laws, even

if we successfully defend against it, could cause us to incur significant legal expenses and divert management’s attention

from the operation of our business.

Moreover, achieving and sustaining compliance with applicable federal and state privacy, security

and fraud laws may prove costly.

third-party contract manufacturers upon whom we rely to formulate and manufacture our product candidates do not perform, fail

to manufacture according to our specifications or fail to comply with strict regulations, our pre-clinical studies or clinical

the federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual, for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

the Omnibus Budget Reconciliation Act of

1993 (42 U.S.C.

1395nn) (the “Stark Law”) prohibit referrals by a physician of “designated health services”

which are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician's immediate

family member has an investment interest or other financial relationship, subject to several exceptions.

The Stark Law also prohibits

billing for services rendered pursuant to a prohibited referral.

Several states have enacted laws similar to the Stark Law.

state laws may cover all (not just Medicare and Medicaid) patients.

Many federal healthcare reform proposals in the past few years

have attempted to expand the Stark Law to cover all patients as well.

If we violate the Stark Law, our financial results and operations

could be adversely affected.

Penalties for violations include denial of payment for the services, significant civil monetary penalties,

and exclusion from the Medicare and Medicaid programs.

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent, and which may apply to entities like us which provide coding and billing information to customers;

the federal Health Insurance Portability and Accountability

Act of 1996, the Health Information and Technology for Economic and Clinical Health Act and their implementing regulations at 45

Parts 160, 162 and 164, as amended (“HIPAA”) which imposes certain requirements relating to the privacy, security

and transmission of protected health information which includes individually identifiable health information, demographic data,

medical histories and test results;

the FDCA which among other things, strictly regulates drug manufacturing and product marketing, prohibits manufacturers from marketing drug products for off-label use and regulates the distribution of drug samples;

state law equivalents of each of the above federal laws, such as, Stark Law, anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal laws, thus complicating compliance efforts.

If our operations are found to be in violation

of any of the laws described above or any governmental regulations that apply to us, we may be subject to penalties, including

civil and criminal penalties, damages, fines and the curtailment or restructuring of our operations.

Any penalties, damages, fines,

curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results.

Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot

be entirely eliminated.

Any action against us for violation of these laws, even if we successfully defend against it, could cause

us to incur significant legal expenses and divert management’s attention from the operation of our business.

Moreover, achieving

and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

If a third-party contract manufacturing

organization (“CMO”) upon whom we rely to formulate and manufacture our product candidates does not perform, fails

to manufacture according to our specifications or fails to comply with strict regulations, our pre-clinical studies or clinical

trials could be adversely affected and the development of our product candidates could be delayed or terminated or we could incur

significant additional expenses.

do not own or operate any manufacturing facilities.

We intend to rely on third-party contractors, at least for the foreseeable

future, to formulate and manufacture these pre-clinical and clinical materials.

Our reliance on third-party contract manufacturers

exposes us to a number of risks, any of which could delay or prevent the completion of our pre-clinical studies or clinical trials,

or the regulatory approval or commercialization of our product candidates, result in higher costs, or deprive us of potential

product revenues.

We do not own or operate any manufacturing

We rely on and intend to continue to rely on CMOs to formulate and manufacture our pre-clinical and clinical materials.

Our reliance on a CMO exposes us to a number of risks, any of which could delay or prevent the completion of our pre-clinical studies

or clinical trials, or the regulatory approval or commercialization of our product candidates, result in higher costs, or deprive

us of potential product revenues.

Some of these risks include:

third-party contractors failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization

our CMO failing to develop an acceptable formulation to support later-stage clinical trials for, or the commercialization of, our product candidates;

our CMO failing to manufacture our product candidate according to our specifications, the FDA’s cGMP requirements, or otherwise manufacturing material that we or the FDA may deem to be unsuitable in our clinical trials;

our CMO being unable to increase the scale of, increase the capacity for, or reformulate the form of our product candidates.

We may experience a shortage in supply, or the cost to manufacture our products may increase to the point where it may adversely affect the cost of our product candidates.

We cannot assure you that our CMO will be able to manufacture our product candidates at a suitable scale, or we will be able to find alternative manufacturers acceptable to us that can do so;

our CMO placing a priority on the manufacture of their own products, or other customers’

our CMO failing to perform as agreed upon or not remain in business;

our CMO’s plants being closed as a result of regulatory sanctions, natural disasters, health epidemics or otherwise.

Manufacturers of pharmaceutical products are

subject to ongoing periodic inspections by the FDA, the U.S.

Drug Enforcement Administration and corresponding state and foreign

agencies to ensure strict compliance with FDA mandated cGMPs, other government regulations and corresponding foreign standards.

While we are obligated to audit their performance, we do not have control over our CMO’s compliance with these regulations

and standards.

Failure by any of our CMOs, or us, to comply with applicable regulations could result in sanctions being imposed

on us or the CMOs.

These sanctions may include fines, injunctions, civil penalties, failure of the government to grant pre-market

approval of drugs, delays, suspension or withdrawal of approvals, seizures or recalls of product, operating restrictions and criminal

prosecutions, any of which could significantly and adversely affect our business.

In the event that we need to change our

CMOs, our pre-clinical studies, clinical trials or the commercialization of our product candidates could be delayed, adversely

affected or terminated, or such a change may result in significantly higher costs.

Various steps in the manufacture of our product

candidates may need to be sole-sourced.

In accordance with cGMP, changing manufacturers may require the re-validation of manufacturing

processes and procedures, and may require further pre-clinical studies or clinical trials to show comparability between the materials

produced by different manufacturers.

Changing our current or future CMOs may be difficult for us and could be costly, which could

result in our inability to manufacture our product candidates for an extended period of time and therefore a delay in the development

of our product candidates.

contract manufacturers failing to manufacture our product candidate according to their own standards, our specifications,

the FDA’s cGMP requirements, or otherwise manufacturing material that we or the FDA may deem to be unsuitable in our

clinical trials;

contract manufacturers being unable to increase the scale of, increase the capacity for, or reformulate the form of our product

We may experience a shortage in supply, or the cost to manufacture our products may increase to the point where

it adversely affects the cost of our product candidates.

We cannot assure you that our contract manufacturers will be able

to manufacture our product candidates at a suitable scale, or we will be able to find alternative manufacturers acceptable

to us that can do so;

contract manufacturers placing a priority on the manufacture of their own products, or other customers’

contract manufacturers failing to perform as agreed or not remain in the contract manufacturing business;

contract manufacturers’

plants being closed as a result of regulatory sanctions or a natural disaster.

Manufacturers

of pharmaceutical products are subject to ongoing periodic inspections by the FDA, the U.S.

Drug Enforcement Administration and

corresponding state and foreign agencies to ensure strict compliance with FDA-mandated cGMPs, other government

regulations and corresponding foreign standards.

While we are obligated to audit their performance, we do not have control over

our third-party contract manufacturers’

compliance with these regulations and standards.

Failure by our third-party manufacturers,

or us, to comply with applicable regulations could result in sanctions being imposed on us or the drug manufacturer from the production

of other third-party products.

These sanctions may include fines, injunctions, civil penalties, failure of the government to grant pre-market approval of

drugs, delays, suspension or withdrawal of approvals, seizures or recalls of product, operating restrictions and criminal prosecutions,

any of which could significantly and adversely affect our business.

the event that we need to change our third-party contract manufacturers, our pre-clinical studies, clinical trials or the commercialization

of our product candidate could be delayed, adversely affected or terminated, or such a change may result in significantly higher

steps in the manufacture of our product candidate may need to be sole-sourced.

In accordance with cGMPs, changing manufacturers

may require the re-validation of manufacturing processes and procedures, and may require further pre-clinical

studies or clinical trials to show comparability between the materials produced by different manufacturers.

Changing our current

or future contract manufacturers may be difficult for us and could be costly, which could result in our inability to manufacture

our product candidates for an extended period of time and therefore a delay in the development of our product candidates.

in order to maintain our development time lines in the event of a change in our third-party contract manufacturer, we may incur

significantly higher costs to manufacture our product candidates.

Reform in the United States.

the United States, there have been, and continue to be, a number of legislative and regulatory changes and proposed changes to

the healthcare system that could affect the future results of pharmaceutical manufactures’

In particular, there

have been and continue to be a number of initiatives at the federal and state levels that seek to reduce healthcare costs.

recently, the Patient Protection and Affordable Care Act (“PPACA”) was enacted in March 2010, which includes measures

to significantly change the way healthcare is financed by both governmental and private insurers.

Among the provisions of the

PPACA of greatest importance to the pharmaceutical and biotechnology industry are the following:

annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents,

apportioned among these entities according to their market share in certain government healthcare programs;

implementation

of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine

licensure framework for follow-on biologic products;

new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness

research, along with funding for such research;

establishment

of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and

service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13%

of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for

innovator drugs at 100% of the Average Manufacturer Price;

new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs

and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;

of manufacturers’

Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed

care organizations;

of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional

individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal

poverty level, thereby potentially increasing manufacturers’

Further, in order to maintain our development time lines in the event of a change in our CMOs, we may

incur significantly higher costs to manufacture our product candidates.

Healthcare Reform in the United States.

In the United States, there have been, and

continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect

the future results of pharmaceutical manufactures’

In particular, there have been and continue to be a number

of initiatives at the federal and state levels that seek to reduce healthcare costs.

Most recently, the Affordable Care Act (“ACA”) was enacted in March 2010, which includes measures to significantly change the way healthcare

is financed by both governmental and private insurers.

Among the provisions of the ACA of greatest importance to the pharmaceutical

and biotechnology industry are the following:

an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;

implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act”;

a licensure framework for follow-on biologic products;

a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending;

an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program, to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price;

a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics, including our product candidates, that are inhaled, infused, instilled, implanted or injected;

extension of manufacturers’

Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’

Medicaid rebate liability;

new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts

off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition

for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

of the entities eligible for discounts under the Public Health program.

of the provisions of the PPACA have yet to be implemented, and there have been legal and political challenges to certain aspects

of the PPACA.

Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent,

or loosen certain requirements mandated by the PPACA.

Concurrently, Congress has considered legislation that would repeal or repeal

and replace all or part of the PPACA.

While Congress has not passed repeal legislation, the Tax Cuts and Jobs Act of 2017 includes

a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed by the PPACA

on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to

a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

expansion of the entities eligible for discounts under the Public Health program.

Some of the provisions of the ACA have

yet to be implemented, and there have been legal and political challenges to certain aspects of the ACA.

The Administration

has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated

Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the

While Congress has not passed repeal legislation, the Tax Cuts and Jobs Act of 2017 includes a provision repealing,

effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail

to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual

mandate”.

Congress may consider other legislation to repeal or replace elements of the ACA.

Many of the details regarding the

implementation of the ACA are yet to be determined, and at this time, the full effect that the ACA would have on a

pharmaceutical manufacturer remains unclear.

This uncertainty is heightened by President Biden’s January 28, 2021

Executive Order on Strengthening Medicaid and the Affordable Care Act which indicates that the

incoming Biden Administration may significantly modify the ACA and potentially revoke any changes implemented by

the Trump Administration.

It is also possible that President Biden will further reform the ACA and other federal programs in

manner that may impact our operations.

The Biden Administration has indicated that a goal of its administration is to

expand and support Medicaid and the ACA and to make high-quality healthcare accessible and affordable.

The potential increase

in patients covered by government funded insurance may impact our pricing.

Further, it is possible that the Biden

Administration may further increase the scrutiny on drug pricing.

Additionally,

on December 14, 2018, a Texas U.S.

District Court Judge ruled that the ACA is unconstitutional in its entirety because the tax

penalty on certain individuals who fail to maintain qualifying health coverage for all or part of a year, commonly referred to

as the “individual mandate.”

Congress may consider other legislation to repeal or replace elements of the PPACA.

of the details regarding the implementation of the PPACA are yet to be determined, and at this time, the full effect that the

PPACA would have on a pharmaceutical manufacturer remains unclear.

In particular, there is uncertainty surrounding the applicability

of the biosimilars provisions under the PPACA.

The FDA has issued several guidance documents, but no implementing regulations,

on biosimilars.

Additionally, on December 18, 2019, the U.S.

Court of Appeals for the 5th Circuit ruled

that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining

provisions of the ACA are invalid as well.

The United States Supreme Court is currently reviewing this case, but it is unclear when

a decision will be made.

It is also unclear how the Supreme Court ruling, other such litigation and the healthcare reform measures

of the Biden administration will impact the ACA.

We cannot predict the likelihood, nature or extent of government regulation

that may arise from future legislation or administrative or executive action, either in the United States or abroad.

that additional state and federal health care reform measures will be adopted in the future, any of which could limit the amounts

that federal and state governments will pay for health care products and services.

Moreover, the Biden administration, including

his nominee for Secretary of DHHS, has indicated that lowering prescription drug prices is a priority, but we do not yet know what

steps the administration will take or whether such steps will be successful.

Further, there is uncertainty surrounding the

applicability of the biosimilars provisions under the ACA.

The FDA has issued several guidance documents, but no implementing

regulations, on biosimilars.

A number of biosimilar applications have been approved over the past few years.

The regulations that are ultimately

promulgated and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers conduct their

business and may require changes to current strategies.

A biosimilar is a biological product that is highly similar to an approved

drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences

between the biological product and the approved drug in terms of the safety, purity, and potency of the product.

states have become increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical

and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product

access, and marketing cost disclosure and transparency measures, and to encourage importation from other countries and bulk purchasing.

Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm a pharmaceutical manufacturer’s

business, results of operations, financial condition and prospects.

In addition, regional healthcare authorities and individual

hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included

in their prescription drug and other healthcare programs.

This could reduce ultimate demand for certain products or put pressure

product pricing, which could negatively affect a pharmaceutical manufacturer’s business, results of operations, financial

condition and prospects.

addition, given recent federal and state government initiatives directed at lowering the total cost of healthcare, Congress and

state legislatures will likely continue to focus on healthcare reform, the cost of prescription drugs and biologics and the reform

of the Medicare and Medicaid programs.

While no one cannot predict the full outcome of any such legislation, it may result in

decreased reimbursement for drugs and biologics, which may further exacerbate industry-wide pressure to reduce prescription drug

This could harm a pharmaceutical manufacturer’s ability to generate revenue.

Increases in importation or re-importation of

pharmaceutical products from foreign countries into the United States could put competitive pressure on a pharmaceutical manufacturer’s

ability to profitably price products, which, in turn, could adversely affect business, results of operations, financial condition

and prospects.

A pharmaceutical manufacturer might elect not to seek approval for or market products in foreign jurisdictions

in order to minimize the risk of re-importation, which could also reduce the revenue generated from product sales.

is also possible that other legislative proposals having similar effects will be adopted.

regulatory authorities’

assessment of the data and results required to demonstrate safety and efficacy can change over time

and can be affected by many factors, such as the emergence of new information, including on other products, changing policies

and agency funding, staffing and leadership.

We cannot be sure whether future changes to the regulatory environment will be favorable

or unfavorable to our business prospects.

For example, average review times at the FDA for marketing approval applications can

be affected by a variety of factors, including budget and funding levels and statutory, regulatory and policy changes.

funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other

personnel, prevent new products and services from being developed or commercialized in a timely manner, affect whether government

agencies promptly pay amounts awarded under grants from such agencies, or otherwise prevent those agencies from performing normal

business functions on which the operation of our business may rely, which could negatively impact our business.

ability of the FDA to review and approve new drugs and medical devices can be affected by a variety of factors, including government

budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory,

and policy changes.

Average review times at the FDA have fluctuated in recent years as a result.

In addition, government funding

of the SEC and other government agencies on which our operations may rely, including those that fund research and development

activities is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for new drugs and medical devices to be reviewed and/or approved

by necessary government agencies as well as affect whether we receive timely payment of amounts awarded to us under grants and

contracts with government agencies which would adversely affect our business.

For example, over the last several years, including

from December 22, 2018 until January 25, 2019, the U.S.

government has shut down several times and certain regulatory agencies,

such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our

regulatory submissions, which could have a material adverse effect on our business.

Further, in our operations as a public company,

future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to

properly capitalize and continue our operations.

threats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our

reputation and business.

is essential to our business strategy that our technology and network infrastructure and our physical buildings remain secure

and are perceived by our customers and corporate partners to be secure.

Despite security measures, however, any network infrastructure

may be vulnerable to cyber-attacks by hackers and other security threats.

We may face cyber-attacks that attempt to penetrate

our network security, sabotage or otherwise disable our research, products and services, misappropriate our or our customers’

The regulations that

are ultimately promulgated and their implementation are likely to have considerable impact on the way pharmaceutical manufacturers

conduct their business and may require changes to current strategies.

A biosimilar is a biological product that is highly similar

to an approved drug notwithstanding minor differences in clinically inactive components, and for which there are no clinically

meaningful differences between the biological product and the approved drug in terms of the safety, purity, and potency of the

Individual states have become increasingly

aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing,

including price or patient reimbursement constraints, discounts, restrictions on certain product access, and marketing cost disclosure

and transparency measures, and to encourage importation from other countries and bulk purchasing.

Legally mandated price controls

on payment amounts by third-party payors or other restrictions could harm a pharmaceutical manufacturer’s business, results

of operations, financial condition and prospects.

In addition, regional healthcare authorities and individual hospitals are increasingly

using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug

and other healthcare programs.

This could reduce ultimate demand for certain products or put pressure product pricing, which could

negatively affect a pharmaceutical manufacturer’s business, results of operations, financial condition and prospects.

In addition, given recent federal and state

government initiatives directed at lowering the total cost of healthcare, Congress and state legislatures will likely continue

to focus on healthcare reform, the cost of prescription drugs and biologics and the reform of the Medicare and Medicaid programs.

While no one cannot predict the full outcome of any such legislation, it may result in decreased reimbursement for drugs and biologics,

which may further exacerbate industry-wide pressure to reduce prescription drug prices.

This could harm a pharmaceutical manufacturer’s

ability to generate revenue.

Increases in importation or re-importation of pharmaceutical products from foreign countries into

the United States could put competitive pressure on a pharmaceutical manufacturer’s ability to profitably price products,

which, in turn, could adversely affect business, results of operations, financial condition and prospects.

A pharmaceutical manufacturer

might elect not to seek approval for or market products in foreign jurisdictions in order to minimize the risk of re-importation,

which could also reduce the revenue generated from product sales.

It is also possible that other legislative proposals having similar

effects will be adopted.

Furthermore, regulatory authorities’

assessment of the data and results required to demonstrate safety and efficacy can change over time and can be affected by many

factors, such as the emergence of new information, including on other products, changing policies and agency funding, staffing

and leadership.

We cannot be sure whether future changes to the regulatory environment will be favorable or unfavorable to our

business prospects.

For example, average review times at the FDA for marketing approval applications can be affected by a variety

of factors, including budget and funding levels and statutory, regulatory and policy changes.

Security threats to our information technology

infrastructure and/or our physical buildings could expose us to liability and damage our reputation and business.

It is essential to our business strategy that

our technology and network infrastructure and our physical buildings remain secure and are perceived by our customers and corporate

partners to be secure.

Despite security measures, however, any network infrastructure may be vulnerable to cyber-attacks by hackers

and other security threats.

We may face cyber-attacks that attempt to penetrate our network security, sabotage or otherwise disable

our research, products and services, misappropriate our or our customers’

and partners’

proprietary information, which may include personally identifiable information, or cause interruptions of

our internal systems and services.

Despite security measures, we also cannot guarantee security of our physical buildings.

building penetration or any cyber-attacks could negatively affect our reputation, damage our network infrastructure and our ability

to deploy our products and services, harm our relationship with customers and partners that are affected, and expose us to financial

Additionally,

there are a number of state, federal and international laws protecting the privacy and security of health information and personal

For example, the HIPAA imposes limitations on the use and disclosure of an individual’s healthcare information by

healthcare providers, healthcare clearinghouses, and health insurance plans, or, collectively, covered entities, and also grants

individuals rights with respect to their health information.

HIPAA also imposes compliance obligations and corresponding penalties for non-compliance

on individuals and entities that provide services to healthcare providers and other covered entities.

As part of the American

Recovery and Reinvestment Act of 2009 (“ARRA”) the privacy and security provisions of HIPAA were amended.

made significant increases in the penalties for improper use or disclosure of an individual’s health information under HIPAA

and extended enforcement authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted

in 2013, HIPAA also imposes notification requirements on covered entities in the event that certain health information has been

inappropriately accessed or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification

to local and national media.

Notification is not required under HIPAA if the health information that is improperly used or disclosed

is deemed secured in accordance with encryption or other standards developed by the U.S.

proprietary information, which

may include personally identifiable information, or cause interruptions of our internal systems and services.

Despite security

measures, we also cannot guarantee security of our physical buildings.

Physical building penetration or any cyber-attacks could

negatively affect our reputation, damage our network infrastructure and our ability to deploy our products and services, harm our

relationship with customers and partners that are affected, and expose us to financial liability.

Additionally, there are a number of state,

federal and international laws protecting the privacy and security of health information and personal data.

For example, HIPAA

imposes limitations on the use and disclosure of an individual’s healthcare information by healthcare providers, healthcare

clearinghouses, and health insurance plans, or, collectively, covered entities, and also grants individuals rights with respect

to their health information.

HIPAA also imposes compliance obligations and corresponding penalties for non-compliance on individuals

and entities that provide services to healthcare providers and other covered entities.

As part of the American Recovery and Reinvestment

Act of 2009 (“ARRA”) the privacy and security provisions of HIPAA were amended.

ARRA also made significant increases

in the penalties for improper use or disclosure of an individual’s health information under HIPAA and extended enforcement

authority to state attorneys general.

As amended by ARRA and subsequently by the final omnibus rule adopted in 2013, HIPAA also

imposes notification requirements on covered entities in the event that certain health information has been inappropriately accessed

or disclosed, notification requirements to individuals, federal regulators, and in some cases, notification to local and national

Notification is not required under HIPAA if the health information that is improperly used or disclosed is deemed secured

in accordance with encryption or other standards developed by the U.S.

Department of Health and Human Services.

Most states have laws requiring notification of affected individuals and/or state regulators in the event of a breach of personal

information, which is a broader class of information than the health information protected by HIPAA.

Many state laws impose significant

data security requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.

Activities outside of the U.S.

implicate local and national data protection standards, impose additional compliance requirements

and generate additional risks of enforcement for non-compliance.

We may be required to expend significant

capital and other resources to ensure ongoing compliance with applicable privacy and data security laws, to protect against security

breaches and hackers or to alleviate problems caused by such breaches.

Relating to Our Intellectual Property Rights

rely on licenses granted to us by Chelexa, the University of Cincinnati, Zylö, North Carolina State University and George

Washington University, and if such licensors do not adequately defend such licenses, our business may be harmed.

primary asset is a sublicense agreement with Chelexa pursuant to which Chelexa has granted us an exclusive sublicense to use its

BioLexa Platform, a proprietary, patented, drug compound platform developed at the University of Cincinnati.

The license enables

us to develop the platform for any indications in humans.

In addition, we entered into an exclusive license agreement with the

University of Cincinnati with respect to a patented, novel genetic marker for food allergies.

We also entered into the Sublicense

Agreement with Zylö

in connection with the development of a treatment for patients suffering from CLE including patents with

respect thereto developed by Albert Einstein College of Medicine.

We have also entered into a license agreement with NCSU with

respect to NCSU’s exon skipping approach for treating allergic diseases, and a license agreement with GW with respect to

aprepitant as used in treating side effects from drugs used for the treatment of cancer.

We rely on the Chelexa, the University

of Cincinnati, Zylö, Albert Einstein College of Medicine, NCSU and GW to and otherwise protect the intellectual property,

including the patents, covered by our licenses.

We have limited control over the activities of Chelexa, the University of Cincinnati,

Zylö, Albert Einstein College of Medicine, NCSU, GW or over any other intellectual property that may be related to the BioLexa

Platform, the genetic marker, CLE, exon skipping approach for treating allergic diseases or aprepitant.

For example, we cannot

be certain that activities by Chelexa, the University of Cincinnati, Zylö, Albert Einstein College of Medicine, NCSU or GW

have been or will be conducted in compliance with applicable laws and regulations.

We may have no control or input over whether,

and in what manner, the University of Cincinnati, Albert Einstein College of Medicine, NCSU and/or GW may enforce or defend the

patents against a third-party.

The University of Cincinnati, Albert Einstein College of Medicine, NCSU and/or GW may enforce or

defend the patent less vigorously than if we had enforced or defended the patents ourselves.

Further, the University of Cincinnati,

Albert Einstein College of Medicine, NCSU and/or GW may not necessarily seek enforcement in scenarios in which we would feel that

enforcement was in our best interests.

For example, the University of Cincinnati, Albert Einstein College of Medicine, NCSU and/or

GW may not enforce the patents against a competitor of ours who is not a direct competitor of the University of Cincinnati, Albert

Einstein College of Medicine, NCSU or GW, as applicable.

If our in-licensed intellectual property is found to be invalid or unenforceable,

then the University of Cincinnati, Albert Einstein College of Medicine, NCSU and/or GW may not be able to enforce the patents

against a competitor of ours.

If we fail to meet our obligations under the sublicense agreement with Chelexa or Chelexa fails

to meet its obligations under its license agreement with the University of Cincinnati, then the University of Cincinnati may terminate

the license agreement with Chelexa thereby terminating our sublicense agreement with Chelexa, and we will be unable to conduct

our business.

Similarly, if we fail to meet our obligations under the sublicense agreement with Zylö

meet its obligations under its license agreement with Albert Einstein College of Medicine, then Albert Einstein College of Medicine

may terminate the license agreement with Zylö

thereby terminating our sublicense agreement with Zylö, and we will be

unable to conduct our business with respect to the development of treatment for patients suffering from CLE.

In addition, if we

fail to meet our obligations under the license agreement with the University of Cincinnati, NCSU or GW then the University of

Cincinnati, NCSU or GW, as applicable, may terminate our license agreement, and we will be unable to continue to use their products

in our business.

Although we may choose to terminate our license agreements, doing so would allow a third party to seek and obtain

an exclusive license to the BioLexa Platform, the genetic marker and the patents relating to CLE NCSU’s exon skipping approach

for treating allergic diseases and aprepitant, If a third party obtains an exclusive license to intellectual property with respect

to the foregoing products and technologies formerly licensed to us, then the third party may seek to enforce the intellectual

property against us which may have a material adverse effect on our business.

are dependent upon our sublicense agreement with Chelexa with respect to the BioLexa Platform and Zylö

with respect the development

of a treatment for patients suffering from CLE;

however, we have no control over the license agreement between Chelexa and the

University of Cincinnati or the license agreement between Zylö

and Albert Einstein College of Medicine.

sublicense agreements with Chelexa and Zylö

are subject to many risks and uncertainties.

Although we are dependent upon our

sublicense agreement with Chelexa with respect to the BioLexa Platform and Zylö

with respect the development of a treatment

for patients suffering from CLE, we have no control over the license agreement between Chelexa and the University of Cincinnati

pursuant to which the University of Cincinnati licensed the BioLexa Platform to Chelexa or the license agreement between Zylö

and Albert Einstein College of Medicine pursuant to which Albert Einstein College of Medicine licensed certain patent rights relating

to CLE to Zylö.

In the event that Chelexa is unable to fulfill its obligations to the University of Cincinnati pursuant to

the terms of its license agreement, the University of Cincinnati may terminate the license thereby voiding our sublicense.

in the event that Zylö

is unable to fulfill its obligations to Albert Einstein College of Medicine pursuant to the terms

of its license agreement, Albert Einstein College of Medicine may terminate the license thereby voiding our sublicense.

event that either the license agreement between Chelexa and the University of Cincinnati or the license agreement between Zylö

and Albert Einstein College of Medicine is terminated, there may be a material adverse effect upon our business.

business depends upon securing and protecting critical intellectual property.

we do not own and only license intellectual property, to the extent we develop intellectual property, our commercial success will

depend in part on obtaining and maintaining patent, trade secret, copyright and trademark protection of our technologies in the

United States and other jurisdictions as well as successfully enforcing and defending such intellectual property rights against

third-party challenges.

We will only be able to protect our intellectual property from unauthorized use by third parties to the

extent that valid and enforceable intellectual property protection, such as patents or trade secrets, cover them.

In particular,

we place considerable emphasis on obtaining patent and trade secret protection for significant new technologies, products and

Furthermore, the degree of future protection of our proprietary rights is uncertain because legal means afford only

limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.

the degree of future protection of our proprietary rights is uncertain for products that are currently in the early stages of

development because we cannot predict which of these products will ultimately reach the commercial market or whether the commercial

versions of these products will incorporate proprietary technologies.

positions in our industry are highly uncertain and involve complex legal and factual questions.

Accordingly, we cannot predict

the breadth of claims that may be allowed or enforced in our patents or in third-party patents.

For example, we or our licensors

might not have been the first to make the inventions covered by our pending patent applications and issued patents, as applicable;

we or our licensors might not have been the first to file patent applications for these inventions;

others may independently develop

similar or alternative technologies or duplicate any of our technologies;

it is possible that none of our pending patent applications

or the pending patent applications of our licensors will result in issued patents;

our issued patents and issued patents of our

licensors may not provide a basis for commercially viable technologies, or may not provide us with any competitive advantages,

or may be challenged and invalidated by third parties;

Most states have

laws requiring notification of affected individuals and/or state regulators in the event of a breach of personal information, which

is a broader class of information than the health information protected by HIPAA.

Many state laws impose significant data security

requirements, such as encryption or mandatory contractual terms, to ensure ongoing protection of personal information.

outside of the U.S.

implicate local and national data protection standards, impose additional compliance requirements and generate

additional risks of enforcement for non-compliance.

We may be required to expend significant capital and other resources to ensure

ongoing compliance with applicable privacy and data security laws, to protect against security breaches and hackers or to alleviate

problems caused by such breaches.

Risks Relating to Our Intellectual Property

We rely upon licenses granted to us by

various licensors, and if such licensors do not adequately defend such licenses, our business may be harmed.

We have entered into and may, in the future,

enter into license and sublicense agreements with respect to our product candidates.

We have limited control over the activities

of our licensors, and we rely upon our licensors to protect their intellectual property, including the patents covered by our licenses.

We cannot be certain that activities conducted by our licensors have been or will be conducted in compliance with applicable laws

and regulations.

Furthermore, we have no or limited control or input over whether, and in what manner, our licensors may enforce

or defend the patents that we license against a third-party.

Our licensors may defend the patents we license less vigorously than

if we had enforced or defended the patents ourselves.

Furthermore, our licensors may not necessarily seek enforcement in scenarios

in which we would feel that enforcement was in our best interests.

For example, our licensors may not enforce the patents against

a competitor of ours who is not a direct competitor of such licensor.

If our in-licensed intellectual property is found to be invalid

or unenforceable, then our licensors may not be able to enforce the patents against a competitor of ours.

Moreover, if we fail

to meet our obligations under our license agreements, the licensor may terminate the license agreement.

Furthermore, if we fail

to meet our obligations under our sublicense agreements or our sublicensor fails to meet its obligations to the licensor, such

licensor may terminate the license agreement thereby terminating our sublicense agreement.

Our business depends upon us securing

and protecting critical intellectual property.

Although we do not own and only license intellectual

property, to the extent we develop intellectual property, our commercial success will depend in part on obtaining and maintaining

patent, trade secret, copyright and trademark protection of our technologies in the United States and other jurisdictions as well

as successfully enforcing and defending such intellectual property rights against third-party challenges.

We will only be able

to protect our intellectual property from unauthorized use by third parties to the extent that valid and enforceable intellectual

property protection, such as patents or trade secrets, cover them.

In particular, we place considerable emphasis on obtaining patent

and trade secret protection for significant new technologies, products and processes.

Furthermore, the degree of future protection

of our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights

or permit us to gain or keep our competitive advantage.

Moreover, the degree of future protection of our proprietary rights is

uncertain for products that are currently in the early stages of development because we cannot predict which of these products

will ultimately reach the commercial market or whether the commercial versions of these products will incorporate proprietary technologies.

Patent positions in our industry are

highly uncertain and involve complex legal and factual questions.

Patent positions in our industry are highly

uncertain and involve complex legal and factual questions.

Accordingly, we cannot predict the breadth of claims that may be allowed

or enforced in our patents or in third-party patents.

For example, we or our licensors might not have been the first to make the

inventions covered by our pending patent applications and issued patents, as applicable;

we or our licensors might not have been

the first to file patent applications for these inventions;

others may independently develop similar or alternative technologies

or duplicate any of our technologies;

it is possible that none of our pending patent applications or the pending patent applications

of our licensors will result in issued patents;

our issued patents and issued patents of our licensors may not provide a basis

for commercially viable technologies, or may not provide us with any competitive advantages, or may be challenged and invalidated

by third parties;

and, we may not develop additional proprietary technologies that are patentable.

a result, our owned and licensed patents may not be valid and we may not be able to obtain and enforce patents and to maintain

trade secret protection for the full commercial extent of our technology.

The extent to which we are unable to do so could materially

harm our business.

or our licensors have applied for and will continue to apply for patents for certain products.

Such applications may not result

in the issuance of any patents, and any patents now held or that may be issued may not provide us with adequate protection from

Furthermore, it is possible that patents issued or licensed to us may be challenged successfully.

In that event,

if we have a preferred competitive position because of such patents, any preferred position held by us would be lost.

unable to secure or to continue to maintain a preferred position, we could become subject to competition from the sale of generic

Failure to receive, inability to protect, or expiration of our patents for medical use, manufacture, conjugation and

labeling of BioLexa, the product platform that we license from Chelexa, or subsequent related filings, would adversely affect

our business and operations.

issued or licensed to us may be infringed by the products or processes of others.

The cost of enforcing our patent rights against

infringers, if such enforcement is required, could be significant, and we do not currently have the financial resources to fund

such litigation.

Further, such litigation can go on for years and the time demands could interfere with our normal operations.

There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical

We may become a party to patent litigation and other proceedings.

The cost to us of any patent litigation, even if resolved

in our favor, could be substantial.

Some of our competitors may be able to sustain the costs of such litigation more effectively

than we can because of their substantially greater financial resources.

As a result, our owned and licensed

patents may not be valid and we may not be able to obtain and enforce patents and to maintain trade secret protection for the full

commercial extent of our technology.

The extent to which we are unable to do so could materially harm our business.

We or our licensors have applied for and will

continue to apply for patents for certain products.

Such applications may not result in the issuance of any patents, and any patents

now held or that may be issued may not provide us with adequate protection from competition.

Furthermore, it is possible that patents

issued or licensed to us may be challenged successfully.

In that event, if we have a preferred competitive position because of

such patents, any preferred position held by us would be lost.

If we are unable to secure or to continue to maintain a preferred

position, we could become subject to competition from the sale of generic products.

Failure to receive, inability to protect, or

expiration of our patents for medical use, manufacture, conjugation and labeling of any of our product candidates may adversely

affect our business and operations.

Patents issued or licensed to us may be infringed

by the products or processes of others.

The cost of enforcing our patent rights against infringers, if such enforcement is required,

could be significant, and we do not currently have the financial resources to fund such litigation.

Further, such litigation can

go on for years and the time demands could interfere with our normal operations.

There has been substantial litigation and other

proceedings regarding patent and other intellectual property rights in the pharmaceutical industry.

We may become a party to patent

litigation and other proceedings.

The cost to us of any patent litigation, even if resolved in our favor, could be substantial.

Some of our competitors may be able to sustain the costs of such litigation more effectively than we can because of their substantially

greater financial resources.

Litigation may also absorb significant management time.

trade secrets, improvements, confidential know-how and continuing technological innovation are important to our scientific and

commercial success.

Although we attempt to and will continue to attempt to protect our proprietary information through reliance

on trade secret laws and the use of confidentiality agreements with our corporate partners, collaborators, employees and consultants

and other appropriate means, these measures may not effectively prevent disclosure of our proprietary information, and, in any

event, others may develop independently, or obtain access to, the same or similar information.

patent rights for our primary product are licensed to us by third parties.

If we fail to comply with the terms of these license

agreements, our rights to those patents may be terminated, and we will be unable to conduct our business.

we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our product development

efforts, obtain a license to continue the development or sale of our products, and/or pay damages.

manufacturing processes and potential products may violate proprietary rights of patents that have been or may be granted to competitors,

universities or others, or the trade secrets of those persons and entities.

As the pharmaceutical industry expands and more patents

are issued, the risk increases that our processes and potential products may give rise to claims that they infringe the patents

or trade secrets of others.

These other persons could bring legal actions against us claiming damages and seeking to enjoin clinical

testing, manufacturing and marketing of the affected product or process.

If any of these actions are successful, in addition to

any potential liability for damages, we could be required to obtain a license in order to continue to conduct clinical tests,

manufacture or market the affected product or use the affected process.

Required licenses may not be available on acceptable terms,

if at all, and the results of litigation are uncertain.

If we become involved in litigation or other proceedings, it could consume

a substantial portion of our financial resources and the efforts of our personnel.

ability to protect and enforce any patents we may obtain does not guaranty that we will secure the right to commercialize such

patent is a limited monopoly right conferred upon an inventor, and his successors in title, in return for the making and disclosing

of a new and non-obvious invention.

This monopoly is of limited duration but, while in force, allows the patent holder to prevent

others from making and/or using his invention.

While a patent gives the holder this right to exclude others, it is not a license

to commercialize the invention, where other permissions may be required for permissible commercialization to occur.

a drug cannot be marketed without the appropriate authorization from the FDA, regardless of the existence of a patent covering

Further, the invention, even if patented itself, cannot be commercialized if it infringes the valid patent rights

of another party.

rely on confidentiality agreements to protect our trade secrets.

If these agreements are breached by our employees or other parties,

our trade secrets may become known to our competitors.

rely on trade secrets which we seek to protect through confidentiality agreements with our employees and other parties.

agreements are breached, our competitors may obtain and use our trade secrets to gain a competitive advantage over us.

not have any remedies against our competitors and any remedies that may be available to us may not be adequate to protect our

business or compensate us for the damaging disclosure.

In addition, we may have to expend resources to protect our interests from

possible infringement by others.

Risks to the Company

have expanded and may continue to expand, our business through the acquisition of rights to new drug candidates that could disrupt

our business, harm our financial condition and may also dilute current shareholders’

Unpatented trade secrets, improvements, confidential

know-how and continuing technological innovation are important to our scientific and commercial success.

Although we attempt to

and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of confidentiality

agreements with our corporate partners, collaborators, employees and consultants and other appropriate means, these measures may

not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain

access to, the same or similar information.

If we are found to be infringing on patents

or trade secrets owned by others, we may be forced to cease or alter our product development efforts, obtain a license to continue

the development or sale of our products, and/or pay damages.

Our manufacturing processes and potential products

may violate proprietary rights of patents that have been or may be granted to competitors, universities or others, or the trade

secrets of those persons and entities.

As the pharmaceutical industry expands and more patents are issued, the risk increases that

our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others.

persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing

of the affected product or process.

If any of these actions are successful, in addition to any potential liability for damages,

we could be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product

or use the affected process.

Required licenses may not be available on acceptable terms, if at all, and the results of litigation

are uncertain.

If we become involved in litigation or other proceedings, it could consume a substantial portion of our financial

resources and the efforts of our personnel.

Our ability to protect and enforce any

patents we may obtain does not guaranty that we will secure the right to commercialize such patents.

A patent is a limited monopoly right conferred

upon an inventor, and his successors in title, in return for the making and disclosing of a new and non-obvious invention.

monopoly is of limited duration but, while in force, allows the patent holder to prevent others from making and/or using his invention.

While a patent gives the holder this right to exclude others, it is not a license to commercialize the invention, where other permissions

may be required for permissible commercialization to occur.

For example, a drug cannot be marketed without the appropriate authorization

from the FDA, regardless of the existence of a patent covering the product.

Further, the invention, even if patented itself, cannot

be commercialized if it infringes the valid patent rights of another party.

We rely on confidentiality agreements

to protect our trade secrets.

If these agreements are breached by our employees or other parties, our trade secrets may become

known to our competitors.

We rely on trade secrets which we seek to protect

through confidentiality agreements with our employees and other parties.

If these agreements are breached, our competitors may

obtain and use our trade secrets to gain a competitive advantage over us.

We may not have any remedies against our competitors

and any remedies that may be available to us may not be adequate to protect our business or compensate us for the damaging disclosure.

In addition, we may have to expend resources to protect our interests from possible infringement by others.

Related Risks to the Company

We have expanded and may continue to

expand, our business through the acquisition of rights to new drug candidates that could disrupt our business, harm our financial

condition and may also dilute current shareholders’

ownership interests in our Company.

business strategy includes expanding our products and capabilities, and we may seek acquisitions of additional drug candidates

or technologies to do so.

Acquisitions involve numerous risks, including substantial cash expenditures;

potentially dilutive issuance

of equity securities;

incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify

at the time of acquisition;

difficulties in assimilating the acquired technologies or the operations of the acquired companies;

diverting our management’s attention away from other business concerns;

risks of entering markets in which we have limited

or no direct experience;

and the potential loss of our key employees or key employees of the acquired companies.

cannot assure you that any acquisition will result in short-term or long-term benefits to us.

We may misjudge the value or worth

of an acquired product, company or business.

In addition, our future success would depend in part on our ability to manage the

rapid growth associated with acquisitions.

We cannot assure you that we will be able to make the combination of our business with

that of acquired products, businesses or companies work or be successful.

Furthermore, the development or expansion of our business

or any acquired products, business or companies may require a substantial capital investment by us.

We may not have these necessary

funds or they might not be available to us on acceptable terms or at all.

We may also seek to raise funds by selling shares of

our preferred or common stock, which could dilute each current shareholder’s ownership interest in the Company.

may undertake international operations, which will subject us to risks inherent with operations outside of the United States.

we do not have any foreign operations at this time, we intend to seek to obtain market clearances in foreign markets that we deem

to generate significant opportunities.

However, even with the cooperation of a commercialization partner, conducting drug development

in foreign countries involves inherent risks, including, but not limited to:

difficulties in staffing, funding and managing foreign

Our business strategy includes expanding our

products and capabilities, and we may seek acquisitions of additional drug candidates or technologies to do so.

Acquisitions involve

numerous risks, including substantial cash expenditures;

potentially dilutive issuance of equity securities;

incurrence of debt

and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition;

difficulties in

assimilating the acquired technologies or the operations of the acquired companies;

diverting our management’s attention

away from other business concerns;

risks of entering markets in which we have limited or no direct experience;

and the potential

loss of our key employees or key employees of the acquired companies.

We cannot assure you that any acquisition will

result in short-term or long-term benefits to us.

We may misjudge the value or worth of an acquired product, company or business.

In addition, our future success would depend in part on our ability to manage the rapid growth associated with acquisitions.

cannot assure you that we will be able to make the combination of our business with that of acquired products, businesses or companies

work or be successful.

Furthermore, the development or expansion of our business or any acquired products, business or companies

may require a substantial capital investment by us.

We may not have these necessary funds or they might not be available to us

on acceptable terms or at all.

We may also seek to raise funds by selling shares of our preferred or common stock, which could

dilute each current shareholder’s ownership interest in the Company.

Any international operations we undertake

may subject us to risks inherent with operations outside of the United States.

We may seek to obtain market clearance for

in foreign markets that we deem to generate significant opportunities.

However, even with the cooperation of a commercialization

partner, conducting drug development in foreign countries involves inherent risks, including, but not limited to:

in staffing, funding and managing foreign operations;

unexpected changes in regulatory requirements;

export restrictions;

tariffs and other trade barriers;

in protecting, acquiring, enforcing and litigating intellectual property rights;

fluctuations in currency exchange rates;

potentially adverse tax consequences.

we were to experience any of the difficulties listed above, or any other difficulties, any international development activities

and our overall financial condition may suffer and cause us to reduce or discontinue our international development and registration

may not be successful in hiring and retaining key employees, including executive officers.

future operations and successes depend in large part upon the strength of our management team.

We rely heavily on the continued

service of Robb Knie, our President and Chief Executive Officer.

Accordingly, if Mr.

Knie terminates his employment with us, such

a departure may have a material adverse effect on our business, and our future success depends on our ability to identify, attract,

hire or engage, retain and motivate other well-qualified financial, managerial, technical, clinical and regulatory personnel.

There can be no assurance that these professionals will be available in the market, or that we will be able to retain existing

professionals or to meet or to continue to meet their compensation requirements.

Furthermore, the cost base in relation to such

compensation, which may include equity compensation, may increase significantly, which could have a material adverse effect on

Failure to establish and maintain an effective management team and work force could adversely affect our ability to operate,

grow and manage our business.

our growth as we expand operations may strain our resources.

expect to grow rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our drug

candidates, which will place a significant strain on our financial, managerial and operational resources.

In order to achieve

and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.

we will need to increase staffing and to train, motivate and manage our employees.

All of these activities will increase our expenses

and may require us to raise additional capital sooner than expected.

Failure to manage growth effectively could harm our business,

financial condition or results of operations.

a product liability claim is successfully brought against us for uninsured liabilities, or such claim exceeds our insurance coverage,

we could be forced to pay substantial damage awards that could materially harm our business.

use of any of our existing or future product candidates in clinical trials and the sale of any approved pharmaceutical products

may expose us to significant product liability claims.

We currently do not have product liability insurance coverage but we intend

to obtain such insurance.

Such insurance coverage may not protect us against any or all of the product liability claims that may

be brought against us in the future.

We may not be able to acquire or maintain adequate product liability insurance coverage at

a commercially reasonable cost or in sufficient amounts or scope to protect us against potential losses.

In the event a product

liability claim is brought against us, we may be required to pay legal and other expenses to defend the claim, as well as uncovered

damage awards resulting from a claim brought successfully against us.

In the event our product candidate is approved for sale

by the FDA and commercialized, we may need to substantially increase the amount of our product liability coverage.

Defending any

product liability claim or claims could require us to expend significant financial and managerial resources, which could have

an adverse effect on our business.

Related to Our Common Stock

price of our common stock may fluctuate substantially.

should consider an investment in our common stock to be risky, and you should invest in our common stock only if you can withstand

a significant loss and wide fluctuations in the market value of your investment.

Some factors that may cause the market price

of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors”

section and elsewhere

in this Annual Report on Form 10-K, are:

of our common stock by our shareholders, executives, and directors;

and limitations in trading volumes of our shares of common stock;

ability to obtain financings to conduct and complete research and development activities including, but not limited to, our

clinical trials, and other business activities;

timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics

of our industry, including consolidation among competitors;

ability to attract new customers;

ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement,

enrollment or results of our clinical trials for our product candidates or any future clinical trials we may conduct;

in the development status of our product candidates;

delays or adverse developments or perceived adverse developments with respect to the FDA’s review of our planned pre-clinical

and clinical trials;

delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory

approval for our product candidates;

unanticipated

safety concerns related to the use of our product candidates;

in our capital structure or dividend policy, future issuances of securities, sales of large blocks of common stock by our

shareholders;

cash position;

announcements

and events surrounding financing efforts, including debt and equity securities;

inability to enter into new markets or develop new products;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or

our competitors;

in general economic, political and market conditions in or any of the regions in which we conduct our business;

in industry conditions or perceptions;

research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial

condition and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us

to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.

may acquire other companies or technologies, which could divert our management’s attention, result in dilution to our stockholders

and otherwise disrupt our operations and adversely affect our operating results.

may in the future seek to acquire or invest in businesses, applications and services or technologies that we believe could complement

or expand our services, enhance our technical capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions

may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable

acquisitions, whether or not they are consummated.

addition, we do not have any experience in acquiring other businesses.

If we acquire additional businesses, we may not be able

to integrate the acquired personnel, operations and technologies successfully, or effectively manage the combined business following

the acquisition.

We also may not achieve the anticipated benefits from the acquired business due to a number of factors, including:

to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated

costs or liabilities associated with the acquisition;

integrating the accounting systems, operations and personnel of the acquired business;

and additional expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

converting the customers of the acquired business onto our platform and contract terms, including disparities in the revenue,

licensing, support or professional services model of the acquired company;

of management’s attention from other business concerns;

effects to our existing business relationships with business partners and customers as a result of the acquisition;

potential loss of key employees;

of resources that are needed in other parts of our business;

of substantial portions of our available cash to consummate the acquisition.

addition, a significant portion of the purchase price of companies we acquire may be allocated to acquired goodwill and other

intangible assets, which must be assessed for impairment at least annually.

In the future, if our acquisitions do not yield expected

returns, we may be required to take charges to our operating results based on this impairment assessment process, which could

adversely affect our results of operations.

and other trade barriers;

difficulties in protecting, acquiring, enforcing and litigating intellectual property rights;

in currency exchange rates;

and potentially adverse tax consequences.

If we were to experience any of the difficulties listed above,

or any other difficulties, our international development activities and our overall financial condition may suffer and cause us

to reduce or discontinue our international development and registration efforts.

We may not be successful in hiring and

retaining key employees, including executive officers.

Our future operations and successes depend

in large part upon the strength of our management team.

We rely heavily on the continued service of each member of our management

Accordingly, if any member of our management team were to terminate their employment with us, such departure may have a material

adverse effect on our business.

In addition, our future success depends on our ability to identify, attract, hire or engage, retain

and motivate other well-qualified financial, managerial, technical, clinical and regulatory personnel.

There can be no assurance

that these professionals will be available in the market, or that we will be able to retain existing professionals or to meet or

to continue to meet their compensation requirements.

Furthermore, the cost base in relation to such compensation, which may include

equity compensation, may increase significantly, which could have a material adverse effect on us.

Failure to establish and maintain

an effective management team and work force could adversely affect our ability to operate, grow and manage our business.

Managing our growth as we expand operations

may strain our resources.

We expect to grow rapidly in order to support

additional, larger, and potentially international, pivotal clinical trials of our drug candidates, which will place a significant

strain on our financial, managerial and operational resources.

In order to achieve and manage growth effectively, we must continue

to improve and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to

train, motivate and manage our employees.

All of these activities will increase our expenses and may require us to raise additional

capital sooner than expected.

Failure to manage growth effectively could harm our business, financial condition or results of operations.

If a product liability claim is successfully

brought against us for uninsured liabilities, or such claim exceeds our insurance coverage, we could be forced to pay substantial

damage awards that could materially harm our business.

The use of any of our existing or future product

candidates in clinical trials and the sale of any approved pharmaceutical products may expose us to significant product liability

We currently do not have product liability insurance coverage but we intend to obtain such insurance.

Such insurance coverage

may not protect us against any or all of the product liability claims that may be brought against us in the future.

be able to acquire or maintain adequate product liability insurance coverage at a commercially reasonable cost or in sufficient

amounts or scope to protect us against potential losses.

In the event a product liability claim is brought against us, we may be

required to pay legal and other expenses to defend the claim, as well as uncovered damage awards resulting from a claim brought

successfully against us.

In the event our product candidate is approved for sale by the FDA or other regulatory agency and commercialized,

we may need to substantially increase the amount of our product liability coverage.

Defending any product liability claim or claims

could require us to expend significant financial and managerial resources, which could have an adverse effect on our business.

Our business may be adversely affected

by the ongoing coronavirus pandemic.

The outbreak of the

novel Coronavirus (COVID-19) evolved into a global pandemic.

The coronavirus has spread to many regions of the world.

to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain

and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain

the coronavirus or treat its impact, among others.

Should the coronavirus

continue to spread, our business operations could be delayed or interrupted.

For instance, our clinical trials may be affected

by the pandemic.

Site initiation, participant recruitment and enrollment, participant dosing, distribution of clinical trial materials,

study monitoring and data analysis may be paused or delayed due to changes in hospital or university policies, federal, state or

local regulations, prioritization of hospital resources toward pandemic efforts, or other reasons related to the pandemic.

coronavirus continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols.

For example, quarantines or other travel limitations (whether voluntary or required) may impede participant movement, affect sponsor

access to study sites, or interrupt healthcare services, and we may be unable to conduct our clinical trials.

Further, if the spread

of the coronavirus pandemic continues and our operations are adversely impacted, we risk a delay, default and/or nonperformance

under existing agreements which may increase our costs.

These cost increases may not be fully recoverable or adequately covered

by insurance.

Infections and deaths

related to the pandemic may disrupt the United States’

healthcare and healthcare regulatory systems.

Such disruptions could

divert healthcare resources away from, or materially delay FDA review and/or approval with respect to, our clinical trials.

is unknown how long these disruptions could continue, were they to occur.

Any elongation or de-prioritization of our

clinical trials or delay in regulatory review resulting from such disruptions could materially affect the development and study

of our product candidates.

We currently utilize

third parties to, among other things, manufacture raw materials.

If either any third-party parties in the supply chain for materials

used in the production of our product candidates are adversely impacted by restrictions resulting from the coronavirus outbreak,

our supply chain may be disrupted, limiting our ability to manufacture our product candidates for our clinical trials and research

and development operations.

In the event of a shelter-in-place order

or other mandated local travel restrictions, our employees conducting research and development or manufacturing activities may

not be able to access their laboratory or manufacturing space, and our core activities may be significantly limited or curtailed,

possibly for an extended period of time.

The spread of the

coronavirus, which has caused a broad impact globally, including restrictions on travel and quarantine policies put into place

by businesses and governments, may have a material economic effect on our business.

While the potential economic impact brought

by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further,

significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable

In addition, a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus

could materially and adversely affect our business and the value of our common stock.

The ultimate impact

of the current pandemic, or any other health epidemic, is highly uncertain and subject to change.

We do not yet know the full extent

of potential delays or impacts on our business, our clinical trials, our research programs, healthcare systems or the global economy

However, these effects could have a material impact on our operations, and we will continue to monitor the situation

Risks Related to Our Common Stock

The price of our common stock may fluctuate substantially.

You should consider an investment in our common

stock to be risky, and you should invest in our common stock only if you can withstand a significant loss and wide fluctuations

in the market value of your investment.

Some factors that may cause the market price of our common stock to fluctuate, in addition

to the other risks mentioned in this “Risk Factors”

section and elsewhere in this Annual Report on Form 10-K, are:

sale of our common stock by our shareholders, executives, and directors;

volatility and limitations in trading volumes of our shares of common stock;

our ability to obtain financings to conduct and complete research and development activities including, but not limited to, our clinical trials, and other business activities;

the timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors;

our ability to attract new customers;

our ability to secure resources and the necessary personnel to conduct clinical trials on our desired schedule;

commencement, enrollment or results of our clinical trials for our product candidates;

changes in the development status of our product candidates;

any delays or adverse developments or perceived adverse developments with respect to a regulatory agency’s review of our planned pre-clinical and clinical trials;

any delay in our submission for studies or product approvals or adverse regulatory decisions, including failure to receive regulatory approval for our product candidates;

unanticipated safety concerns related to the use of our product candidates;

changes in our capital structure or dividend policy, future issuances of securities and sales of large blocks of common stock by our shareholders;

our cash position;

announcements and events surrounding financing efforts, including debt and equity securities;

our inability to enter into new markets or develop new products;

reputational issues;

announcements of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

changes in general economic, political and market conditions in or any of the regions in which we conduct our business;

changes in industry conditions or perceptions;

analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

departures and additions of key personnel;

disputes and litigations related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws, rules, regulations, or accounting practices and other dynamics;

other events or factors, many of which may be out of our control, including, but not limited to, pandemics such as COVID-19, war, or other acts of God.

In addition, if the market for stocks in our

industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the

trading price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations.

If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful,

could be costly to defend and a distraction to management.

We may acquire other companies or technologies,

which could divert our management’s attention, result in dilution to our shareholders and otherwise disrupt our operations

and adversely affect our operating results.

We may in the future seek to acquire or invest

in businesses, applications and services or technologies that we believe could complement or expand our services, enhance our technical

capabilities or otherwise offer growth opportunities.

The pursuit of potential acquisitions may divert the attention of management

and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are

In addition, we do not have any experience

in acquiring other businesses.

If we acquire additional businesses, we may not be able to integrate the acquired personnel, operations

and technologies successfully, or effectively manage the combined business following the acquisition.

We also may not achieve the

anticipated benefits from the acquired business due to a number of factors, including:

inability to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated costs or liabilities associated with the acquisition;

difficulty integrating the accounting systems, operations and personnel of the acquired business;

difficulties and additional expenses associated with supporting legacy products and hosting infrastructure of the acquired business;

difficulty converting the customers of the acquired business onto our platform and contract terms, including disparities in the revenue, licensing, support or professional services model of the acquired company;

diversion of management’s attention from other business concerns;

adverse effects to our existing business relationships with business partners and customers as a result of the acquisition;

the potential loss of key employees;

use of resources that are needed in other parts of our business;

use of substantial portions of our available cash to consummate the acquisition.

In addition, a significant portion of the purchase

price of companies we acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed for impairment

at least annually.

In the future, if our acquisitions do not yield expected returns, we may be required to take charges to our

operating results based on this impairment assessment process, which could adversely affect our results of operations.

could also result in dilutive issuances of equity securities or the incurrence of debt, which could adversely affect our operating

In addition, if an acquired business fails to meet our expectations, our operating results, business and financial position

and economic conditions may negatively impact our business, financial condition and share price.

over inflation, energy costs, geopolitical issues, the U.S.

mortgage market and a declining real estate market, unstable global

credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished

liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the

global economy and expectations of slower global economic growth going forward, increased unemployment rates, and increased credit

defaults in recent years.

Our general business strategy may be adversely affected by any such economic downturns, volatile business

environments and continued unstable or unpredictable economic and market conditions.

If these conditions continue to deteriorate

or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive.

Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our

growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization

securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business,

our stock price and trading volume may decline.

trading market for our common stock will rely in part on the research and reports that industry or financial analysts publish

about us, our business, our markets and our competitors.

Market and economic conditions may negatively

impact our business, financial condition and share price.

Concerns over inflation, energy costs, geopolitical

issues, the U.S.

mortgage market and a declining real estate market, unstable global credit markets and financial conditions, and

volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit availability, declines

in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global

economic growth going forward, increased unemployment rates, and increased credit defaults in recent years.

Our general business

strategy may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable

economic and market conditions.

If these conditions continue to deteriorate or do not improve, it may make any necessary debt or

equity financing more difficult to complete, more costly, and more dilutive.

Failure to secure any necessary financing in a timely

manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price

and could require us to delay or abandon development or commercialization plans.

If securities or industry analysts do

not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume

The trading market for our common stock will

rely in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our

We do not control these analysts.

If securities analysts do not cover

our common stock, the lack of research coverage may adversely affect the market price of our common stock.

Furthermore, if one

or more of the analysts who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or

our business, our stock price would likely decline.

If one or more of these analysts cease coverage of us or fails to regularly

publish reports on us, we could lose visibility in the market and interest in our stock could decrease, which in turn could cause

our stock price or trading volume to decline and may also impair our ability to expand our business with existing customers and

attract new customers.

certain of our shareholders control a significant number of shares of our common stock, they may have effective control over actions

requiring shareholder approval.

As of February 28, 2020, our directors and executive officers

and their respective affiliates, beneficially own approximately 20.93% of our outstanding shares of common stock on a fully diluted

As a result, these shareholders acting together, would have the ability to control the outcome of matters submitted to

our shareholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially

all of our assets.

In addition, these shareholders, acting together, would have the ability to control the management and affairs

of our Company.

If securities analysts do not cover our common stock, the lack of research coverage

may adversely affect the market price of our common stock.

Furthermore, if one or more of the analysts who do cover us downgrade

our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price would likely decline.

If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose visibility in

the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline and

may also impair our ability to expand our business with existing customers and attract new customers.

Because certain of our shareholders

control a significant number of shares of our common stock, they may have effective control over actions requiring shareholder

As of March 11, 2021, our directors, executive

officers, certain of our shareholders and their respective affiliates, beneficially own approximately 39.88% of our outstanding

shares of common stock.

As a result, these shareholders acting together, may have the ability to control the outcome of matters

submitted to our shareholders for approval, including the election of directors and any merger, consolidation or sale of all or

substantially all of our assets.

In addition, these shareholders, acting together, may have the ability to control the management

and affairs of our Company.

Accordingly, this concentration of ownership might harm the market price of our common stock by:

deferring or preventing a change in corporate control;

a merger, consolidation, takeover or other business combination involving us;

a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

sales and issuances of our securities could result in additional dilution of the percentage ownership of our shareholders and

could cause our share price to fall.

expect that significant additional capital will be needed in the future to continue our planned operations, including research

and development, increased marketing, hiring new personnel, commercializing our products, and continuing activities as an operating

public company.

To the extent we raise additional capital by issuing equity securities, our shareholders may experience substantial

We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and

in a manner we determine from time to time.

If we sell common stock, convertible securities or other equity securities in more

than one transaction, investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution

to our existing shareholders, and new investors could gain rights superior to our existing shareholders.

do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not

anticipate declaring or paying any cash dividends for the foreseeable future.

Any return to shareholders will therefore be limited

to the increase, if any, of our share price.

are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable

to emerging growth companies, which could make our common stock less attractive to investors.

are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS

Act”), and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to

other public companies that are not “emerging growth companies”

including not being required to comply with the auditor

attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”),

reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from

the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute

payments not previously approved.

In addition, pursuant to Section 107 of the JOBS Act, as an “emerging growth company”

we intend to take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying

with new or revised accounting standards.

In other words, an “emerging growth company”

can delay the adoption of certain

accounting standards until those standards would otherwise apply to private companies.

We cannot predict if investors will find

our common stock less attractive because we may rely on these exemptions.

If some investors find our common stock less attractive

as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

advantage of these reporting exemptions until we are no longer an “emerging growth company.”

We will remain an “emerging

growth company”

until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues

of $1.07 billion or more;

(ii) the last day of our fiscal year following the fifth anniversary of the date of our initial

public offering;

(iii) the date on which we have issued more than $1 billion in nonconvertible debt during the previous

or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

may be at risk of securities class action litigation.

In the past, biotechnology and pharmaceutical companies have experienced

significant stock price volatility, particularly when associated with binary events such as clinical trials and product approvals.

If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources,

which could harm our business and results in a decline in the market price of our common stock.

are currently listed on The Nasdaq Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock

exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could

be impaired and it may be more difficult for our stockholders to sell their securities.

our common stock is currently listed on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s

minimum listing requirements or those of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid

market for our common stock does not develop or is sustained, our common stock may remain thinly traded.

Listing Rules of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

for any reason, we should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from

trading on its exchange and we are unable to obtain listing on another national securities exchange, a reduction in some or all

of the following may occur, each of which could have a material adverse effect on our stockholders:

liquidity of our common stock;

market price of our common stock;

ability to obtain financing for the continuation of our operations;

number of institutional and general investors that will consider investing in our common stock;

number of investors in general that will consider investing in our common stock;

number of market makers in our common stock;

availability of information concerning the trading prices and volume of our common stock;

number of broker-dealers willing to execute trades in shares of our common stock.

reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will

be required to devote substantial time to compliance matters.

a publicly traded company we incur significant legal, accounting and other expenses.

The obligations of being a public company

in the United States require significant expenditures and places significant demands on our management and other personnel, including

costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate

governance practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection

Act, and the listing requirements of The Nasdaq Capital Market.

These rules require the establishment and maintenance of effective

disclosure and financial controls and procedures, internal control over financial reporting and changes in corporate governance

practices, among many other complex rules that are often difficult to implement, monitor and maintain compliance with.

despite recent reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations will make some activities

more time-consuming and costly, particularly after we are no longer an “emerging growth company.”

In addition, we

expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability

Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all

of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming subject

to litigation or being delisted, among other potential problems.

we fail to comply with the rules under Sarbanes-Oxley related to internal controls and procedures in the future, or, if we discover

material weaknesses and other deficiencies in our internal controls over financial reporting, our stock price could decline significantly

and raising capital could be more difficult.

of Sarbanes-Oxley requires annual management assessments of the effectiveness of our internal controls over financial reporting.

If we fail to comply with the rules under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we

discover material weaknesses and other deficiencies in our internal controls over financial reporting, our stock price could decline

significantly and raising capital could be more difficult.

If material weaknesses or significant deficiencies are discovered or

if we otherwise fail to achieve and maintain the adequacy of our internal controls, we may not be able to ensure that we can conclude

on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal controls are necessary for us to produce reliable financial reports and are important to helping

prevent financial fraud.

If we cannot provide reliable financial reports or prevent fraud, our business and operating results

could be harmed, investors could lose confidence in our reported financial information, and the trading price of our common stock

could drop significantly.

2017 Comprehensive tax reform could adversely affect our business and financial condition.

Tax Cuts and Jobs Act of 2017 (the “Tax Cut Act”) among other things, contains significant changes to corporate taxation,

including reduction of the corporate tax rate from a top marginal rate of 35% to a single rate of 21%, limitation of the tax deduction

for interest expense to 30% of adjusted taxable income (except for certain small businesses), limitation of the deduction for

net operating losses carried forward from taxable years beginning after December 31, 2017 to 80% of current year taxable income

and elimination of net operating loss carrybacks, one time taxation of offshore earnings at reduced rates regardless of whether

they are repatriated, elimination of U.S.

tax on foreign earnings (subject to certain important exceptions), providing immediate

deductions for certain new investments instead of deductions for depreciation expense over time, and modifying or repealing many

business deductions and credits (including reduction of tax credits under the Orphan Drug Act).

Notwithstanding the reduction

in the corporate income tax rate, the overall impact of the Tax Act is uncertain and our business and financial condition could

be adversely affected.

In addition, it is uncertain if, and to what extent, various states will conform to the Tax Act.

our shareholders to consult with their legal and tax advisors with respect to any such legislation and the potential tax consequences

of investing in our securities.

Articles of Incorporation, as amended (“Articles of Incorporation”) our Amended and Restated Bylaws, and Nevada law

may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to

Articles of Incorporation, Amended and Restated Bylaws, and Nevada law could make it more difficult for a third party to acquire

us, even if closing such a transaction would be beneficial to our stockholders.

We are authorized to issue up to 10,000,000 shares

of preferred stock, none of which are outstanding as of February25, 2020.

This preferred stock may be issued in one or more series,

the terms of which may be determined at the time of issuance by our board of directors without further action by shareholders.

The terms of any series of preferred stock may include voting rights (including the right to vote as a series on particular matters),

preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions.

As of February 28, 2020,

5,000,000 shares of our preferred stock have been designated as Series A Preferred Stock of which 3,102,480 shares of Series A

Preferred Stock which were previously issued were converted into common stock at the time of our initial public offering and 1,897,520

shares of Series A Preferred Stock remain authorized.

The issuance of any preferred stock could materially adversely affect the

rights of the holders of our common stock, and therefore, reduce the value of our common stock.

In particular, specific rights

granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assets to, a third

party and thereby preserve control by the present management.

of our Articles of Incorporation, our Amended and Restated Bylaws and Nevada law also could have the effect of discouraging potential

acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a shareholder

might consider favorable.

Such provisions may also prevent or frustrate attempts by our shareholders to replace or remove our

In particular, the Articles of Incorporation, our Amended and Restated Bylaws and Nevada law, as applicable, among

other things:

the board of directors with the ability to alter the Amended and Restated Bylaws without shareholder approval;

limitations on the removal of directors;

advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted

upon at shareholder meetings;

that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Amended and Restated Bylaws provide that the Eighth Judicial District Court of Clark County, Nevada will be the sole and exclusive

forum for certain disputes which could limit stockholders’

ability to obtain a favorable judicial forum for disputes

with the Company or its directors, officers, employees or agents.

Amended and Restated Bylaws provide that unless the Company consents in writing to the selection of an alternative forum, the

Eighth Judicial District Court of Clark County, Nevada shall be the sole and exclusive forum for state law claims with respect

(i) any derivative action or proceeding brought in the name or right of the Company or on its behalf, (ii) any

action asserting a claim for breach of any fiduciary duty owed by any director, officer, employee or agent of the Company to the

Company or the Company’s stockholders, (iii) any action arising or asserting a claim arising pursuant to any provision of

Nevada Revised Statutes Chapters 78 or 92A or any provision of the Company’s Articles of Incorporation or Amended and Restated

Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine, including, without limitation, any

action to interpret, apply, enforce or determine the validity of the Company’s Articles of Incorporation or Amended and

Restated Bylaws.

This exclusive forum provision would not apply to suits brought to enforce any liability or duty created by the

Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

To the extent

that any such claims may be based upon federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction

over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce

any duty or liability created by the Securities Act or the rules and regulations thereunder.

choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable

for disputes with the Company or its directors, officers, other employees or agents, which may discourage such lawsuits against

the Company and its directors, officers, other employees and agents.

Alternatively, if a court were to find the choice of forum

provision contained in our Amended and Restated Bylaws to be inapplicable or unenforceable in an action, the Company may incur

additional costs associated with resolving such action in other jurisdictions, which could have a material adverse effect on the

Company’s business, results of operations, and financial condition.

delaying, deferring or preventing a change in corporate control;

impeding a merger, consolidation, takeover or other business combination involving us;

discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

Future sales and issuances of our securities

could result in additional dilution of the percentage ownership of our shareholders and could cause our share price to fall.

We expect that significant additional capital

will be needed in the future to continue our planned operations, including research and development, increased marketing, hiring

new personnel, commercializing our products, and continuing activities as an operating public company.

To the extent we raise additional

capital by issuing equity securities, our shareholders may experience substantial dilution.

We may sell common stock, convertible

securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.

we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially

diluted by subsequent sales.

Such sales may also result in material dilution to our existing shareholders, and new investors could

gain rights superior to our existing shareholders.

We do not intend

to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares.

We currently anticipate

that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring

or paying any cash dividends for the foreseeable future.

Any return to shareholders will therefore be limited to the increase,

if any, of our share price.

We are an “emerging growth company”

and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make

our common stock less attractive to investors.

We are an “emerging growth company,”

as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and we intend to take advantage of

certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging

growth companies”

including not being required to comply with the auditor attestation requirements of Section 404(b) of the

Sarbanes-Oxley Act of 2002, as amended (“Sarbanes-Oxley”), reduced disclosure obligations regarding executive compensation

in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive

compensation and shareholder approval of any golden parachute payments not previously approved.

In addition, pursuant to Section

107 of the JOBS Act, as an “emerging growth company”

we intend to take advantage of the extended transition period

provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards.

In other words, an

“emerging growth company”

can delay the adoption of certain accounting standards until those standards would otherwise

apply to private companies.

We cannot predict if investors will find our common stock less attractive because we may rely on these

If some investors find our common stock less attractive as a result, there may be a less active trading market for

our common stock and our stock price may be more volatile.

We may take advantage of these reporting exemptions until we are no

longer an “emerging growth company.”

We will remain an “emerging growth company”

until the earliest of

(i) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more;

(ii) the last day of

our fiscal year following the fifth anniversary of the date of our initial public offering;

(iii) the date on which we have issued

more than $1.0 billion in nonconvertible debt during the previous three years;

or (iv) the date on which we are deemed to be a

large accelerated filer under the rules of the SEC.

We may be at risk of securities class action litigation.

We may be at risk of securities class action

In the past, biotechnology and pharmaceutical companies have experienced significant stock price volatility, particularly

when associated with binary events such as clinical trials and product approvals.

If we face such litigation, it could result in

substantial costs and a diversion of management’s attention and resources, which could harm our business and results in a

decline in the market price of our common stock.

We are currently listed on The Nasdaq

Capital Market.

If we are unable to maintain listing of our securities on Nasdaq or any stock exchange, our stock price could be

adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and it may be more difficult

for our shareholders to sell their securities.

Although our common stock is currently listed

on The Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum listing requirements or those

of any other national exchange.

If we are unable to maintain listing on Nasdaq or if a liquid market for our common stock does

not develop or is sustained, our common stock may remain thinly traded.

The Listing Rules of Nasdaq require listing

issuers to comply with certain standards in order to remain listed on its exchange.

If, for any reason, we should fail to maintain

compliance with these listing standards and Nasdaq should delist our securities from trading on its exchange and we are unable

to obtain listing on another national securities exchange, a reduction in some or all of the following may occur, each of which

could have a material adverse effect on our shareholders:

the liquidity of our common stock;

the market price of our common stock;

our ability to obtain financing for the continuation of our operations;

the number of investors that will consider investing in our common stock;

the number of market makers in our common stock;

the availability of information concerning the trading prices and volume of our common stock;

the number of broker-dealers willing to execute trades in shares of our common stock.

Financial reporting obligations of being

a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial

time to compliance matters.

As a publicly traded company we incur significant

legal, accounting and other expenses.

The obligations of being a public company in the United States require significant expenditures

and places significant demands on our management and other personnel, including costs resulting from public company reporting obligations

under the Exchange Act and the rules and regulations regarding corporate governance practices, including those under the Sarbanes-Oxley

Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements of The Nasdaq Capital Market.

These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal control

over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult

to implement, monitor and maintain compliance with.

Moreover, despite recent reforms made possible by the JOBS Act, the reporting

requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after we are no longer

an “emerging growth company.”

Our management and other personnel will need to devote a substantial amount of time to

ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance

and risk becoming subject to litigation or being delisted, among other potential problems.

If we fail to comply with the rules under

Sarbanes-Oxley related to internal controls and procedures in the future, or, if we discover material weaknesses and other deficiencies

in our internal controls over financial reporting, our stock price could decline significantly and raising capital could be more

Section 404 of Sarbanes-Oxley requires annual

management assessments of the effectiveness of our internal controls over financial reporting.

If we fail to comply with the rules

under Sarbanes-Oxley related to disclosure controls and procedures in the future, or, if we discover material weaknesses and other

deficiencies in our internal controls over financial reporting, our stock price could decline significantly and raising capital

could be more difficult.

If material weaknesses or significant deficiencies are discovered or if we otherwise fail to achieve and

maintain the adequacy of our internal controls, we may not be able to ensure that we can conclude on an ongoing basis that we have

effective internal controls over financial reporting in accordance with Section 404 of Sarbanes-Oxley.

Moreover, effective internal

controls are necessary for us to produce reliable financial reports and are important to helping prevent financial fraud.

cannot provide reliable financial reports or prevent fraud, our business and operating results could be harmed, investors could

lose confidence in our reported financial information, and the trading price of our common stock could drop significantly.

Our Articles of Incorporation,

as amended (“Articles of Incorporation”) our Amended and Restated Bylaws, and Nevada law may have anti-takeover effects

that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Our Articles of Incorporation, Amended

and Restated Bylaws, and Nevada law could make it more difficult for a third party to acquire us, even if closing such a transaction

would be beneficial to our shareholders.

We are authorized to issue up to 10,000,000 shares of preferred stock, none of which

are outstanding as of March 11, 2021.

This preferred stock may be issued in one or more series, the terms of which may be determined

at the time of issuance by our board of directors without further action by shareholders.

The terms of any series of preferred

stock may include voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation,

conversion and redemption rights and sinking fund provisions.

As of March 11, 2021, 5,000,000 shares of our preferred stock have

been designated as Series A Preferred Stock of which 3,102,480 shares of Series A Preferred Stock which were previously issued

were converted into common stock at the time of our initial public offering and 1,897,520 shares of Series A Preferred Stock remain

The issuance of any preferred stock could materially adversely affect the rights of the holders of our common stock,

and therefore, reduce the value of our common stock.

In particular, specific rights granted to future holders of preferred stock

could be used to restrict our ability to merge with, or sell our assets to, a third party and thereby preserve control by the

present management.

Provisions of our Articles of Incorporation,

our Amended and Restated Bylaws and Nevada law also could have the effect of discouraging potential acquisition proposals or making

a tender offer or delaying or preventing a change in control, including changes a shareholder might consider favorable.

Such provisions

may also prevent or frustrate attempts by our shareholders to replace or remove our management.

In particular, the Articles of

Incorporation, our Amended and Restated Bylaws and Nevada law, as applicable, among other things:

provide the board of directors with the ability to alter the Amended and Restated Bylaws without shareholder approval;

place limitations on the removal of directors;

establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at shareholder meetings;

provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

Our Amended and Restated Bylaws provide

that the Eighth Judicial District Court of Clark County, Nevada will be the sole and exclusive forum for certain disputes which

could limit shareholders’

ability to obtain a favorable judicial forum for disputes with us or its directors, officers, employees

Our Amended and Restated Bylaws provide that

unless we consent in writing to the selection of an alternative forum, the Eighth Judicial District Court of Clark County, Nevada

shall be the sole and exclusive forum for state law claims with respect to:

(i) any derivative action or proceeding brought in

the name or right of us or on our behalf, (ii) any action asserting a claim for breach of any fiduciary duty owed by any director,

officer, employee or agent to us or our shareholders, (iii) any action arising or asserting a claim arising pursuant to any provision

of Nevada Revised Statutes Chapters 78 or 92A or any provision of our Articles of Incorporation or Amended and Restated Bylaws

or (iv) any action asserting a claim governed by the internal affairs doctrine, including, without limitation, any action to interpret,

apply, enforce or determine the validity of our Articles of Incorporation or Amended and Restated Bylaws.

This exclusive forum

provision would not apply to suits brought to enforce any liability or duty created by the Securities Act or the Exchange Act or

any other claim for which the federal courts have exclusive jurisdiction.

To the extent that any such claims may be based upon

federal law claims, Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any

duty or liability created by the Exchange Act or the rules and regulations thereunder.

Furthermore, Section 22 of the Securities

Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created

by the Securities Act or the rules and regulations thereunder.

This choice of forum provision may limit a

shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors,

officers, other employees or agents, which may discourage such lawsuits against us and our directors, officers, other employees

Alternatively, if a court were to find the choice of forum provision contained in our Amended and Restated Bylaws to

be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions,

which could have a material adverse effect on our business, results of operations, and financial condition.

UNRESOLVED STAFF COMMENTS

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors